New active substances authorized in the United Kingdom between 1972 and 1994

PubMed Central

Jefferys, David B; Leakey, Diane; Lewis, John A; Payne, Sandra; Rawlins, Michael D

1998-01-01

Aims The study was undertaken to assemble a list of all new active medicinal substances authorised in the United Kingdom between 1972 and 1994; to assess whether the pattern of introductions had changed; and to examine withdrawal rates and the reasons for withdrawal. Methods The identities of those new active substances whose manufacturers had obtained Product Licences between 1972 and 1994 were sought from the Medicines Control Agency's product data-base. For each substance relevant information was retrieved including the year of granting the Product Licence, its therapeutic class, whether currently authorised (and, if not, reason for withdrawal), and its nature (chemical, biological etc.). Results The Medicines Control Agency's data-base was cross-checked against two other data-bases for completeness. A total of 583 new active substances (in 579 products) were found to have been authorised over the study period. The annual rates of authorisation varied widely (9 to 40 per year). Whilst there was no evidence for any overall change in the annual rates of authorising new chemical entities, there has been a trend for increasing numbers of new products of biological origin to be authorised in recent years. Fifty-nine of the 583 new active substances have been withdrawn (1 each for quality and efficacy, 22 for safety, and 35 for commercial reasons). Conclusions For reasons that are unclear there is marked heterogeneity in the annual rates of authorisation of new active substances. Their 10 year survival is approximately 88% with withdrawals being, predominantly, for commercial or safety reasons. This confirms the provisional nature of assessments about safety at the time when a new active substance is introduced into routine clinical practice, and emphasises the importance of pharmacovigilance. PMID:9491828

Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.

PubMed

Bouvy, Jacoline C; Blake, Kevin; Slattery, Jim; De Bruin, Marie L; Arlett, Peter; Kurz, Xavier

2017-12-01

Regulatory agencies and other stakeholders increasingly rely on data collected through registries to support their decision-making. Data from registries are a cornerstone of post-marketing surveillance for monitoring the use of medicines in clinical practice. This study was aimed at gaining further insight into the European Medicines Agency's (EMA) requests for new registries and registry studies using existing registries and to review the experience gained in their conduct. European Public Assessment Reports were consulted to identify products for which a request for a registry was made as a condition of the marketing authorisation. All centrally authorised products that received a positive opinion of the EMA Committee for Medicinal Products for Human Use between 1 January 2005 and 31 December 2013 were included. Data regarding registry design and experiences were collected from EMA electronic record keeping systems. Of 392 products that received a positive Committee for Medicinal Products for Human Use opinion during 2005-2013, 31 registries were requested for 30 products in total. Sixty-five percent were product registries whereas 35% were disease registries and 71% of the registries had a primary safety objective. Most commonly reported issues with registries were delayed time to start and low patient accrual rates. The delays found in getting new registries up and running support the need to improve the timeliness of data collection in the post-marketing setting. Methodological challenges met in conducting this study highlighted the need for a clarification of definitions and epidemiological concepts around patient registries. The results will inform the EMA Patient Registry initiative to support use of existing patient registries for the post-authorisation benefit-risk monitoring of medicinal products. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd.

From wastewater to fertilisers--Technical overview and critical review of European legislation governing phosphorus recycling.

PubMed

Hukari, Sirja; Hermann, Ludwig; Nättorp, Anders

2016-01-15

The present paper is based on an analysis of the EU legislation regulating phosphorus recovery and recycling from wastewater stream, in particular as fertiliser. To recover phosphorus, operators need to deal with market regulations, health and environment protection laws. Often, several permits and lengthy authorisation processes for both installation (e.g. environmental impact assessment) and the recovered phosphorus (e.g. End-of-Waste, REACH) are required. Exemptions to certain registration processes for recoverers are in place but rarely applied. National solutions are often needed. Emerging recovery and recycling sectors are affected by legislation in different ways: Wastewater treatment plants are obliged to remove phosphorus but may also recover it in low quantities for operational reasons. Permit processes allowing recovery and recycling operations next to water purification should thus be rationalised. In contrast, the fertiliser industry relies on legal quality requirements, ensuring their market reputation. For start-ups, raw-material sourcing and related legislation will be the key. Phosphorus recycling is governed by fragmented decision-making in regional administrations. Active regulatory support, such as recycling obligation or subsidies, is lacking. Legislation harmonisation, inclusion of recycled phosphorus in existing fertiliser regulations and support of new operators would speed up market penetration of novel technologies, reduce phosphorus losses and safeguard European quality standards.

Keeping mum about dad: "contracts" to protect gamete donor anonymity.

PubMed

Rees, Anne

2012-06-01

This article considers the legal status of so-called contracts for anonymity between fertility clinics and donors of gametes that were made in the period before legislation authorising disclosure. It notes that while clinics frequently cite the existence of these "contracts" to argue against retrospective legislation authorising disclosure of the donor's identity, they may be nothing more than one-sided statements of informed consent. However, the article notes that even if an agreement between a donor and a clinic is not contractual, it does not follow that a person conceived through assisted reproductive technology has any right of access to the identity of the donor. The writer has not been able to locate examples of written promises by the clinics promising anonymity. There are written promises by the donors not to seek the identity of the recipients. These promises do not bind the resulting offspring nor do they appear to be supported by consideration. The article suggests that the basis for any individual donor to restrain a clinic from revealing their identity may be found in promissory estoppel. Nevertheless, there is no real issue in Australia concerning clinics revealing these details absent legislative authority. The issue is whether parliaments will legislate to authorise the disclosure. The article notes that it would be rare for parliaments to legislate to overturn existing legal contracts but suggests that the contract argument may not be as strong as has been thought.

Regulatory landscape for cell therapy--EU view.

PubMed

McBlane, James W

2015-09-01

This article addresses regulation of cell therapies in the European Union (EU), covering cell sourcing and applications for clinical trials and marketing authorisation applications. Regulatory oversight of cell sourcing and review of applications for clinical trials with cell therapies are handled at national level, that is, separately with each country making its own decisions. For clinical trials, this can lead to different decisions in different countries for the same trial. A regulation is soon to come into force that will address this and introduce a more efficient clinical trial application process. However, at the marketing authorisation stage, the process is pan-national: the Committee for Human Medicinal Products (CHMP) is responsible for giving the final scientific opinion on all EU marketing authorisation applications for cell therapies: favourable scientific opinions are passed to the European Commission (EC) for further consultation and, if successful, grant of a marketing authorisation valid in all 28 EU countries. In its review of applications for marketing authorisations (MAAs) for cell therapies, the CHMP is obliged to consult the Committee for Advanced Therapies (CAT), who conduct detailed scientific assessments of these applications, with assessment by staff from national regulatory authorities and specialist advisors to the regulators. Copyright © 2015.

Granting marketing authorisation for medicines in South East European countries: the point of view of the authority.

PubMed

Tomić, Sinisa; Sucić, Anita Filipović; Martinac, Adrijana Ilić

2010-01-01

European legislation for medicines places the emphasis on an assessment of quality, safety and efficacy during the procedure for the granting of marketing authorisations for medicines, in order to protect patient health. The integrated European regulatory system involves the participation of a network of experts from the agencies of the member states that takes part in the European procedures for the authorisation of medicines. On the way to full membership in the EU, candidate countries and potential candidates have to transpose and implement the European directives for medicinal products; they must also strengthen their scientific and administrative capacities. Croatia acquired good experience in implementing the simplified marketing authorisation procedure for medicines authorised in the EU pursuant to the New Collaboration Agreement between Drug Regulatory Authorities in Central and East European Countries (nCADREAC), which helps it to exchange information and prepare for the implementation of European procedures. However, there are still some provisions to transpose before actual full membership, and also dossier upgrading, in which the marketing authorisation holder has to harmonise its documentation about a medicinal product with the requirements of the directives, if a product already on the market was not previously approved in line with current European legislation. Collaboration with the European Medicines Agency (EMA) through an Instrument for Pre-Accession (IPA) provides candidate countries and potential candidates the opportunity for education and training in some regulatory activities as well as the participation of their representatives as observers in some EMA committees and working groups. Some characteristics of the national regulatory frameworks of the countries of South East Europe in their efforts to achieve harmonisation with EU legislation are presented in this paper. Copyright 2010 Elsevier Inc. All rights reserved.

Quality and clinical supply considerations of Paediatric Investigation Plans for IV preparations-A case study with the FP7 CloSed project.

PubMed

Hanning, Sara M; Orlu Gul, Mine; Winslade, Jackie; Baarslag, Manuel A; Neubert, Antje; Tuleu, Catherine

2016-09-25

A Paediatric Investigation Plan (PIP) is a development plan that aims to ensure that sufficient data are obtained through studies in paediatrics to support the generation of marketing authorisation of medicines for children. This paper highlights some practical considerations and challenges with respect to PIP submissions and paediatric clinical trials during the pharmaceutical development phase, using the FP7-funded Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit (CloSed) project as a case study. Examples discussed include challenges and considerations regarding formulation development, blinding and randomisation, product labelling and shipment and clinical trial requirements versus requirements for marketing authorisation. A significant quantity of information is required for PIP submissions and it is hoped that future applicants may benefit from an insight into some critical considerations and challenges faced in the CloSed project. Copyright © 2016 Elsevier B.V. All rights reserved.

Chilean legislation for the control of diseases of aquatic species.

PubMed

Campos Larraín, M C; Valenzuela Alfaro, M E

1996-06-01

The Political Constitution of Chile establishes the right of the people to live in an environment which is free from contamination. The State has a duty to uphold this right and to preserve nature. With the aim of reconciling this constitutional guarantee with the pursuit of profitable economic activities, the concept of 'sustainable development' has been promoted. This mechanism makes it possible to use natural resources and the environment in a rational, effective and efficient manner both at present and in the future, and led to the promulgation of the General Law of Fisheries and Aquaculture No. 18,892 of 6 September 1991 and its amendments. This law regulates national fisheries and aquaculture activities throughout the country, and contains eleven regulations applicable to aquaculture. These regulations form a complete procedure of action relevant to the importation of aquatic species, to applicants for aquaculture concessions and authorisations, to the operation of these concessions and authorisations, and to ocean ranching systems. Due to the complexity of these regulations, important rules are still under study, while the remaining texts come into force on 1 September 1996. Formulating these rules involves consideration of current national and international regulations, the experience of farmers, the results of technical and scientific research, and bibliographical data. These regulations will form the cornerstone of Children aquaculture policy in confronting the challenges of the next century.

SAFARI-1: Achieving conversion to LEU - A local challenge

DOE Office of Scientific and Technical Information (OSTI.GOV)

Piani, C.S.B.

2008-07-15

Two years have passed since the South African Department of Minerals and Energy authorised the conversion from High Enriched Uranium (HEU) to Low Enriched Uranium (LEU) of the South African Research Reactor (SAFARI-1) and the associated fuel manufacturing at Pelindaba. The scheduling, as originally proposed, allowed approximately three years for the full conversion of the reactor, anticipating simultaneous manufacturing ability from the fuel production plant. Due to technical difficulties experienced in the conversion of the local manufacturing plant from HEU (UAl alloy) to LEU (U Silicide) and the uncertainty as to costing and scheduling of such an achievement, the conversionmore » of SAFARI-1 based on local supply has been allocated a lower priority. The acquisition in mid-2006 of 2 LEU silicide elements of SA design, manufactured by AREVA- CERCA and irradiated as test elements in SAFARI-1 to burn-ups of {approx}65% each; was successfully accomplished within 9 cycles of irradiation each. Furthermore, four 'Hybrid' elements (AREVA-CERCA plates assembled locally at Pelindaba) are ready for irradiation and have received regulatory authorisation to load. This will enable the SAFARI-1 conversion program to continue systematically according to an agreed schedule. This paper will trace the developments of the above and reflect the current status and the rescheduled conversion phases of the reactor according to latest expectations. (author)« less

Role of the "National Reference Centre for Genetically Modified Organisms (GMO) detection" in the official control of food and feed.

PubMed

Ciabatti, I; Marchesi, U; Froiio, A; Paternò, A; Ruggeri, M; Amaddeo, D

2005-08-01

The National Reference Centre for Genetically Modified Organisms (GMO) detection was established in 2002 within the Istituto Zooprofilattico Sperimentale Lazio e Toscana, with the aim of providing scientific and technical support to the National Health System and to the Ministry of Health within the scope of the regulation of GMO use in food and feed.The recently adopted EU legislation on GMOs (Regulation CE no. 1829/2003 and no. 1830/2003) introduced more rigorous procedures for the authorisation, labelling and analytical control of food and feed consisting, containing or derived from GMOs. The National Reference Centre, besides its institutional tasks as one of the laboratories of the Italian National Health System, collects and analyses data and results of the national official control of GMOs; carries out scientific research aimed at developing, improving, validating and harmonising detection and quantification methods, in cooperation with other scientific institutions, the Community Reference Laboratory and within the European Network of GMOs laboratories (ENGL); collaborates with the Ministry of Health in the definition of control programmes and promotes educational and training initiatives. Objectives defined for 2004-2006, activities in progress and goals already achieved are presented.

Where is industry getting it wrong? A review of quality concerns raised at Day 120 by the Committee For Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products.

PubMed

Borg, John Joseph; Robert, Jean-Louis; Wade, George; Aislaitner, George; Pirozynski, Michal; Abadie, Eric; Salmonson, Tomas; Vella Bonanno, Patricia

2009-01-01

The aim of this study was to identify common trends in the deficiencies identified in the quality part of the dossier during the evaluation of marketing authorisation applications for medicinal products for human use submitted through the EU's centralised procedure. We analysed all the adopted Day 120 list of questions on the quality module of 52 marketing authorisation applications for chemical entity medicinal products submitted to the European Medicines Agency and evaluated by the Committee for Medicinal Products for Human Use (CHMP), during 12 consecutive plenary meetings held in 2007 and 2008. Subsequently we calculated the frequency of common deficiencies identified across these applications. Frequencies and trends on quality deficiencies have been recorded and presented for 52 marketing authorisation applications. 32 "Major Objections" originated from 13 marketing authorisation applications. 13 concerned were raised regarding drug substances and 19 for drug products. Furthermore, 905 concerns on drug substance and 1,054 on drug product were also adopted. The impact of the frequencies and trends in quality deficiencies that were identified are discussed from a regulatory point of view. It is expected that the results of this study will not only be of interest to pharmaceutical companies but will also aid regulators' in obtaining consistent information on drug products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

[Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].

PubMed

Enzmann, Harald; Broich, Karl

2013-01-01

For innovative oncological medicines the centralised procedure at the European Medicines Agency is mandatory for a marketing authorisation application for the European Union. As with other medical drugs, the marketing authorisation decision is based on the assessment of its efficacy, safety and pharmaceutical quality but does not consider price or reimbursement. More sophisticated diagnostic methods drive an increasing stratification of cancer into a multitude of different diseases. Regardless of their different pathogenesis and therapeutic options the most relevant clinical endpoints remain cure, overall survival and progression free survival. These endpoints include both efficacy and safety, as patient survival reflects the sum of the beneficial anti-tumour effects (increasing survival) AND the adverse effects (decreasing survival). The benefit of an anticancer medicine should be evident from both overall survival and progression free survival (e.g. used as primary and secondary endpoints). Mature data on overall survival may not be needed for marketing authorisation if a clear increase in progression free survival convincingly predicts a beneficial effect on overall survival. In these exceptional cases treatment of patients with an obviously beneficial medicine must not be delayed - possibly for years - until the exact size of the benefit has been established. The continued stratification of the disease cancer results in a lower prevalence for each of the newly distinguished disease entities and an ever increasing number of orphan designations for medicines for rare diseases. Incentives for the development of orphan medicines include market exclusivity for up to ten years. In specific circumstances, however, the orphan legislation may restrict the authorisation and marketing of competing generic products even beyond these ten years. Conditional approval and approval under exceptional circumstances may accelerate patients' access to a new medicine. Both postulate that the extent of the benefit cannot be determined with sufficient certainty at the time of marketing authorisation. This uncertainty may have a negative impact on price and reimbursement as these decisions may consider data or assessments from the marketing authorisation procedure. Therefore, marketing authorisation applications and subsequent pricing and reimbursement negotiations should not be regarded as completely independent processes, but be included in an overall strategy for the development of oncologic drugs. (As supplied by publisher). Copyright © 2013. Published by Elsevier GmbH.

Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations.

PubMed

Lehmann, Birka

2008-12-08

Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective.The same approach may not always be applied to medicinal products used to treat children.Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions.The Regulation (EC) No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children.The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD), for the European Union (EU). The CTD establishes specific provisions regarding conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products and in particular relating to the implementation of good clinical practice. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. The CTD is addressed to all investigators conducting clinical trials including clinical trials in the paediatric population and had to be applied accordingly.In the framework of the authorisation of medicinal products regulated by the Regulation (EC) No 726/2004 and Directive 2001/83/EC as amended and the CTD, and additional implementing Directives and guidelines, the new Regulation (EC) No 1901/2006 is an important new piece of legislation focusing on the requirements to improve the situation for the paediatric population. All Regulations/Directives to be found: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol1_en.htm.

Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations

PubMed Central

Lehmann, Birka

2008-01-01

Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective. The same approach may not always be applied to medicinal products used to treat children. Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions. The Regulation (EC) No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children. The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD), for the European Union (EU). The CTD establishes specific provisions regarding conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products and in particular relating to the implementation of good clinical practice. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. The CTD is addressed to all investigators conducting clinical trials including clinical trials in the paediatric population and had to be applied accordingly. In the framework of the authorisation of medicinal products regulated by the Regulation (EC) No 726/2004 and Directive 2001/83/EC as amended and the CTD, and additional implementing Directives and guidelines, the new Regulation (EC) No 1901/2006 is an important new piece of legislation focusing on the requirements to improve the situation for the paediatric population. All Regulations/Directives to be found: PMID:19063722

A Network Centric Warfare (NCW) Compliance Process for Australian Defence

DTIC Science & Technology

2006-08-01

discovery and access by a wide range of authorised Defence users. The information could be used to simplify future NCW Compliance Assessments by re-using...Security standards 1. General Security Services - General Table 5.1 2. General Security services - Authentication Table 5.2 3. General Security...Personnel Positions in an authorised establishment must be filled by individuals who satisfy the necessary individual readiness requirements

An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making.

PubMed

McNaughton, Rhian; Huet, Gwenaël; Shakir, Saad

2014-01-15

The objective of this study was to determine the nature of evidence used to support the withdrawal of marketing authorisations of drug products for safety reasons throughout the European Union (EU) between 2002 and 2011. Products withdrawn, either by a medicines agency or a marketing authorisation holder, during the period 2002-2011 were identified by conducting detailed searches of the WHO, the European Medicines Agency (EMA) and national medicines agency websites throughout the EU plus Norway, Iceland and Liechtenstein. The scientific evidence used to support the decision was identified from a search within PubMed, the EMA and national medicines agencies websites. Information about spontaneous case reports entered into EudraVigilance and unavailable on the EMA website was received by email from the EMA. 19 drugs were withdrawn from the market, throughout the EU, for safety reasons from 2002 to 2011. Case reports were cited in 95% of withdrawals (18/19) and case-control studies (4/19), cohort studies (4/19), randomised controlled trials (RCTs) (12/19) or meta-analysis (5/19) were cited in 63% of withdrawals (12/19). Cardiovascular events or disorders were the main reason for withdrawal (9/19), followed by hepatic disorders (4/19) and neurological or psychiatric disorders (4/19). This study has shown that the level of evidence used to support drug withdrawal has improved during the past 10 years, with an increased use of case-control studies, cohort studies, RCTs and meta-analyses. This research has demonstrated that such studies have contributed to decision-making in almost two-thirds of cases.

Mapping regulatory models for medicinal cannabis: a matrix of options.

PubMed

Belackova, Vendula; Shanahan, Marian; Ritter, Alison

2017-05-30

Objective The aim of the present study was to develop a framework for assessing regulatory options for medicinal cannabis in Australia. Methods International regulatory regimes for medicinal cannabis were reviewed with a qualitative policy analysis approach and key policy features were synthesised, leading to a conceptual framework that facilitates decision making across multiple dimensions. Results Two central organising dimensions of medicinal cannabis regulation were identified: cannabis supply and patient authorisation (including patient access). A number of the different supply options can be matched with a number of different patient authorisation options, leading to a matrix of possible regulatory regimes. Conclusions The regulatory options, as used internationally, involve different forms of cannabis (synthetic and plant-based pharmaceutical preparations or herbal cannabis) and the varying extent to which patient authorisation policies and procedures are stringently or more loosely defined. The optimal combination of supply and patient authorisation options in any jurisdiction that chooses to make medicinal cannabis accessible will depend on policy goals. What is known about the topic? Internationally, regulation of medicinal cannabis has developed idiosyncratically, depending on formulations that were made available and local context. There has been no attempt to date in the scientific literature to systematically document the variety of regulatory possibilities for medicinal cannabis. What does this paper add? This paper presents a new conceptual schema for considering options for the regulation of medicinal cannabis, across both supply and patient authorisation aspects. What are the implications for practitioners? The design of regulatory systems in Australia, whether for pharmaceutical or herbal products, is a vital issue for policy makers right now as federal and state and territory governments grapple with the complexities of medicinal cannabis regulation. The conceptual schema presented herein provides a tool for more systematic thinking about the options.

European Union centralised procedure for marketing authorisation of oncology drugs: an in-depth review of its efficiency.

PubMed

Netzer, Tilo

2006-03-01

In the European Union (EU) 20 anticancer agents have been successfully authorised via the Centralised Procedure since its implementation in 1995. Public information on these 20 agents has been reviewed in order to evaluate the effectiveness of the available regulatory mechanisms to facilitate the marketing authorisation of such drugs in the EU. These mechanisms include orphan drug legislation, exceptional circumstances provision and the accelerated evaluation procedure. Based on the fact that the EU orphan drug legislation was not implemented before the year 2000 no conclusions on its effectiveness to facilitate oncology drug development can be drawn today. Much more data are available on the effects of the exceptional circumstances provision, which was used in 6 out of 10 cases over the past four years. An analysis of the clinical data packages indicates that this provision allows authorisation of innovative oncology drugs based on smaller clinical data sets than required for full approval. The accelerated evaluation procedure was used in only one case and significantly reduced the scientific review time at the EU agencies. However, this mechanism does not influence the administrative time at the authorities, which accounted for almost one-third of the overall duration of the EU marketing authorisation procedures for oncology drugs. Revision of the EU drug legislation brings about some changes to the above-described provisions, with the potential for an improvement in the current situation. Thus, its implementation offers the chance to reduce the time that innovative oncology agents take to reach the market, although -- based on experience with the current procedures -- more effort is likely to be required to achieve this goal.

Secure FAST: Security Enhancement in the NATO Time Sensitive Targeting Tool

DTIC Science & Technology

2010-11-01

designed to aid in the tracking and prosecuting of Time Sensitive Targets. The FAST tool provides user level authentication and authorisation in terms...level authentication and authorisation in terms of security. It uses operating system level security but does not provide application level security for...and collaboration tool, designed to aid in the tracking and prosecuting of Time Sensitive Targets. The FAST tool provides user level authentication and

[Adolescent vulnerabilities and radicalisation].

PubMed

Lenjalley, Adrien; Radjack, Rahmeth; Ludot, Maude; Touhami, Fatima; Moro, Marie Rose

2017-10-01

Radicalisation resonates with the psychological vulnerabilities of adolescents. The ups and downs encountered as they attempt to construct their identity and their need to dominate favour the destructive nature of young people lacking a sense of filiation and belonging. An adolescent's engagement corresponds to a search for limits, with an adherence to religious values and to a group to establish self-esteem. Subjectification, authorising the adolescent to separate themselves from their parents and their values through a period of crisis must be supported. Copyright © 2017. Published by Elsevier Masson SAS.

Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

PubMed

Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

2015-01-01

With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

Principles for consistent value assessment and sustainable funding of orphan drugs in Europe.

PubMed

Gutierrez, Laura; Patris, Julien; Hutchings, Adam; Cowell, Warren

2015-05-03

The European Orphan Medicinal Products (OMP) Regulation has successfully encouraged research to develop treatments for rare diseases resulting in the authorisation of new OMPs in Europe. While decisions on OMP designation and marketing authorisation are made at the European Union level, reimbursement decisions are made at the national level. OMP value and affordability are high priority issues for policymakers and decisions regarding their pricing and funding are highly complex. There is currently no European consensus on how OMP value should be assessed and inequalities of access to OMPs have previously been observed. Against this background, policy makers in many countries are considering reforms to improve access to OMPs. This paper proposes ten principles to be considered when undertaking such reforms, from the perspective of an OMP manufacturer. We recommend the continued prioritisation of rare diseases by policymakers, an increased alignment between payer and regulatory frameworks, pricing centred on OMP value, and mechanisms to ensure long-term financial sustainability allowing a continuous and virtuous development of OMPs. Our recommendations support the development of more consistent frameworks and encourage collaboration between all stakeholders, including research-based industry, payers, clinicians, and patients.

The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children

PubMed Central

2014-01-01

Background Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment of Paediatric Investigation Plans (PIPs). The effect of the EU Paediatric Drug Regulation on the marketing authorisation (MA) of drugs for children with rare diseases was studied. Methods Data on all designated orphan drugs, their indication, MA, PIPs and indication group (adult or child) were obtained from the European Medicines Agency (EMA). The outcome and duration of the process from orphan drug designation (ODD) to MA, was compared, per indication, by age group. The effect of the Paediatric Drug Regulation, implemented in 2007, on the application process was assessed with survival analysis. Results Eighty-one orphan drugs obtained MA since 2000 and half are authorised for (a subgroup of) children; another 34 are currently undergoing further investigations in children through agreed PIPs. The Paediatric Drug Regulation did not significantly increase the number of ODDs with potential paediatric indications (58% before vs 64% after 2007 of ODDs, p = 0.1) and did not lead to more MAs for ODs with paediatric indications (60% vs 43%, p = 0.22). ODs authorised after 2007 had a longer time to MA than those authorised before 2007 (Hazard ratio (95% CI) 2.80 (1.84-4.28), p < 0.001); potential paediatric use did not influence the time to MA (Hazard ratio (95% CI) 1.14 (0.77-1.70), p = 0.52). Conclusions The EU Paediatric Drug Regulation had a minor impact on development and availability of ODs for children, was associated with a longer time to MA, but ensured the further paediatric development of drugs still off-label to children. The impact of the Paediatric Drug Regulation on research quantity and quality in children through PIPs is not yet clear. PMID:25091201

The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children.

PubMed

Kreeftmeijer-Vegter, Annemarie Rosan; de Boer, Anthonius; van der Vlugt-Meijer, Roselinda H; de Vries, Peter J

2014-08-05

Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment of Paediatric Investigation Plans (PIPs). The effect of the EU Paediatric Drug Regulation on the marketing authorisation (MA) of drugs for children with rare diseases was studied. Data on all designated orphan drugs, their indication, MA, PIPs and indication group (adult or child) were obtained from the European Medicines Agency (EMA). The outcome and duration of the process from orphan drug designation (ODD) to MA, was compared, per indication, by age group. The effect of the Paediatric Drug Regulation, implemented in 2007, on the application process was assessed with survival analysis. Eighty-one orphan drugs obtained MA since 2000 and half are authorised for (a subgroup of) children; another 34 are currently undergoing further investigations in children through agreed PIPs. The Paediatric Drug Regulation did not significantly increase the number of ODDs with potential paediatric indications (58% before vs 64% after 2007 of ODDs, p = 0.1) and did not lead to more MAs for ODs with paediatric indications (60% vs 43%, p = 0.22). ODs authorised after 2007 had a longer time to MA than those authorised before 2007 (Hazard ratio (95% CI) 2.80 (1.84-4.28), p < 0.001); potential paediatric use did not influence the time to MA (Hazard ratio (95% CI) 1.14 (0.77-1.70), p = 0.52). The EU Paediatric Drug Regulation had a minor impact on development and availability of ODs for children, was associated with a longer time to MA, but ensured the further paediatric development of drugs still off-label to children. The impact of the Paediatric Drug Regulation on research quantity and quality in children through PIPs is not yet clear.

[Biological research and security institutes].

PubMed

Darsie, G; Falczuk, A J; Bergmann, I E

2006-04-01

The threat of using biological material for ago-bioterrorist ends has risen in recent years, which means that research and diagnostic laboratories, biological agent banks and other institutions authorised to carry out scientific activities have had to implement biosafety and biosecurity measures to counter the threat, while carrying out activities to help prevent and monitor the accidental or intentional introduction of exotic animal diseases. This article briefly sets outthe basic components of biosafety and biosecurity, as well as recommendations on organisational strategies to consider in laboratories that support agro-bioterrorist surveillance and prevention programs.

[Strategies of medical self-authorization in early modern medicine: the example of Volcher Coiter (1534-1576)].

PubMed

Gross, Dominik; Steinmetzer, Jan

2005-01-01

Based on the example of Volcher Coiter--a town physician at Nuremberg and one of the leading anatomists in early modern medicine--, this essay points out that the authoritative status of contemporary physicians mainly was predicated on an interplay of self-fashioning and outside perception. It provides ample evidence that Coiter made use of several characteristic rhetorical and discourse-related strategies of self-authorisation such as the participation in social networks, a highly convincing technique of self-fashioning by emphasizing particular erudition, the presentation of academic medicine as a science authorised by god and the concurrent devaluation of non-academic healers. Furthermore, graphic and visual strategies of self-authorisation could be ascertained: Coiter took care for a premium typography of his books. He also used his talent as a graphic artist in his books to visualise his medical concepts. Moreover, the so-called 'Nuremberg Portrait' of Coiter served to illustrate his outstanding authority.

[Hope for patients with rare diseases--"orphan" drugs].

PubMed

Kuzelová, M; Kubácková, K; Palágyi, M; Smíd, M

2006-01-01

Rare diseases are defined as those affected less than five in every 10 000 person in European Union. The purpose of this paper is to present activities, which make possible to stimulate research development and marketing of appropriate medicine for tretment of rare disease, named "Orphan" medicinal products. EU "Orphan" medicinal products legislation which entered into force in April 2000 is described. Definition of "Orphan" medicinal products as well as the procedure of designation and placing the products into the Community register is presented. Those incentives to industry are described, which are already five years very well implemented oh the European level mostly on the pre-authorisation phase of "Orphan" medicinal products development, but also in the registration process as well as the post-authorisation phase. Finaly, the first twenty "Orphan" medicinal products, which have been given positive opinion in the Community for the grant of a marketing authorisation till April 2005 are mentioned in this work. The real availability of "Orphan" medicinal products in the particular EU member states is analysed.

[Safety monitoring of cell-based medicinal products (CBMPs)].

PubMed

Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

2015-11-01

Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

Banking (on) the brain: from consent to authorisation and the transformative potential of solidarity.

PubMed

Harmon, Shawn H E; Mcmahon, Aisling

2014-01-01

Modern technologies and biomedicine ambitions have given rise to new models of medical research, including population biobanking. One example of biobanking is brain banking, which refers to the collection and storage of brain and spinal cord samples for research into neurological diseases. Obviously, brain banking involves taking brains and tissue from deceased people, a fact which complicates the role of recruiters and makes consent a poor tool for stakeholders. After contextualising brain banking and considering the public health issues at stake, this article explores the legal definitions and demands of, and actual processes around, consent in England/Wales/Northern Ireland and authorisation in Scotland, articulating and evaluating their conceptual and practical differences. It then argues for an expanded but improved operation of 'authorisation' in the brain banking (and broader biobanking) setting, adopting 'solidarity' as our foundation and the improvement of the 'public good' our objective. © The Author [2014]. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.

Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

PubMed

Cilia, Mark; Ruiz, Sol; Richardson, Peter; Salmonson, Tomas; Serracino-Inglott, Anthony; Wirth, Francesca; Borg, John Joseph

2018-02-01

The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included. Frequencies and trends on quality deficiencies were recorded and presented for 22 biosimilar applications. Thirty-two 'major objections' for 9 products were identified from 14 marketing authorisation applications with 15 raised for drug substance and 17 for drug product. In addition, 547 'other concerns' for drug substance and 495 for drug product were also adopted. The frequencies and trends of the identified deficiencies together with their impact were discussed from a regulatory perspective and how these impact key manufacturing processes and key materials used in the production of biosimilars. This study provides an insight to the regulatory challenges prospective companies need to consider when developing biosimilars; it also helps elucidate common pitfalls in the development and production of biosimilars and in the submission of dossiers for their marketing authorisations. The results are expected to be of interest to pharmaceutical companies but also to regulators to obtain consistent information on medicinal products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

Effect thresholds and 'adequate control' of risks: The fatal flaws in the EU council's position on authorisation within REACH.

PubMed

Santillo, David; Johnston, Paul

2006-10-01

Preparation of the new European REACH (Registration, Evaluation and Authorisation of CHemicals) regulation on chemicals has reached a critical stage. Depending on how key elements of the legislative proposal are finalised, especially that on authorisation of uses of 'substances of very high concern', REACH could either provide an effective measure to drive innovation towards cleaner and safer alternatives, or instead lead to further avoidable chemical exposures on the basis of demonstrated 'adequate control' of risks. Given that some key indicators of human and wildlife reproductive health continue to decline in parts of Europe, while evidence for chemical exposure as a contributory factor grows, it will clearly be vital to get the legislation right. GOAL AND SCOPE: Whereas there is now a consensus between the European Parliament and Council of the European Union that uses of persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances should only be permitted when no safer alternatives are available, major differences remain regarding the manner in which other 'substances of very high concern' (including substances which are carcinogenic, mutagenic or toxic to reproduction (CMRs) and endocrine disruptors) are addressed. This paper examines those differences in more detail and proposes some ways forward. Using case studies of specific chemicals as examples, the paper critically evaluates the concepts of 'effect thresholds' and 'adequate control' of risks, which underpin the Council's proposal for many CMRs and endocrine disruptors. The subjectivity and uncertainties inherent in the threshold approach proposed by the Council, as illustrated by these case examples, bring its ability to ensure a high level of protection for the environment and human health into question: i. the nature and extent of toxic effects recorded depend on many different factors, including the type of test and conditions selected, the organisms exposed, the timing of exposure and precisely which effects are measured and over what timeframe. ii. doses considerably below 'no effect levels' for survival could nevertheless be causing significant impairment to health and/or reproductive success. iii. chemicals present in mixtures at levels below established thresholds for effects may, in combination, induce significant toxicological responses. Under the Council's current proposal, companies will be granted authorisations for some uses of CMRs and endocrine disruptors, even if safer alternatives without these properties are already on the market. The high level of evidence required for identification of substances as being of equivalent concern represents an additional weakness in the Council approach. Instead, a requirement (along the lines of the Parliament's proposals) to address the availability of alternatives in all cases, to use them when available and to initiate their development when not, represents a more robust, defensible and protective approach to the management of 'substances of very high concern'. The possibility for authorisation of essential uses would remain, while all avoidable uses and exposures would progressively be prevented and sustainable innovation supported. In the long run, this can only lead to a more sustainable future for the chemical industry in Europe, as well as delivering benefits of increased protection for our environment and health for generations to come.

[Telematics in the health system and data protection].

PubMed

Müller, J H

2005-06-01

In the health system, telematics are to be used for the benefit of patients and to make it possible for them to receive better medical care. Telematics must be employed in accordance with the guidelines of data protection and this means in particular that the patient must remain the master of his data. Therefore, he must be able to decide in which situation and to whom he wants to reveal his medical data. For this reason, the exact implementation of the introduction of the electronic medical smart card envisaged by the law requires detailed access authorisations and limitations, which must be reinforced by ample technical security measures. These measures must be transmitted to the patients through co-operation of doctors and health insurance companies in such a transparent way that they recognise the advantages of the new technology. The higher the acceptance is on the patients' side, the more they will be willing to participate voluntarily in telematic projects.

Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.

PubMed

Giannuzzi, Viviana; Landi, Annalisa; Bosone, Enrico; Giannuzzi, Floriana; Nicotri, Stefano; Torrent-Farnell, Josep; Bonifazi, Fedele; Felisi, Mariagrazia; Bonifazi, Donato; Ceci, Adriana

2017-09-11

The research and development process in the field of rare diseases is characterised by many well-known difficulties, and a large percentage of orphan medicinal products do not reach the marketing approval.This work aims at identifying orphan medicinal products that failed the developmental process and investigating reasons for and possible factors influencing failures. Drugs designated in Europe under Regulation (European Commission) 141/2000 in the period 2000-2012 were investigated in terms of the following failures: (1) marketing authorisation failures (refused or withdrawn) and (2) drugs abandoned by sponsors during development.Possible risk factors for failure were analysed using statistically validated methods. This study points out that 437 out of 788 designations are still under development, while 219 failed the developmental process. Among the latter, 34 failed the marketing authorisation process and 185 were abandoned during the developmental process. In the first group of drugs (marketing authorisation failures), 50% reached phase II, 47% reached phase III and 3% reached phase I, while in the second group (abandoned drugs), the majority of orphan medicinal products apparently never started the development process, since no data on 48.1% of them were published and the 3.2% did not progress beyond the non-clinical stage.The reasons for failures of marketing authorisation were: efficacy/safety issues (26), insufficient data (12), quality issues (7), regulatory issues on trials (4) and commercial reasons (1). The main causes for abandoned drugs were efficacy/safety issues (reported in 54 cases), inactive companies (25.4%), change of company strategy (8.1%) and drug competition (10.8%). No information concerning reasons for failure was available for 23.2% of the analysed products. This analysis shows that failures occurred in 27.8% of all designations granted in Europe, the main reasons being safety and efficacy issues. Moreover, the stage of development reached by drugs represents a specific risk factor for failures. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[New drugs in oncology--features of clinical trials for market authorisation and arguments for the rapid implementation of independent clinical trials following approval].

PubMed

Ludwig, Wolf-Dieter; Schott, Gisela

2013-01-01

The market authorisation or extension of indication for all oncology drugs in Europe is now based on Regulation (EC) No. 726/2004, a centralised procedure of the European Medicines Agency (EMA). Studies in recent years have highlighted deficiencies in pivotal studies. For example, the requirements of the EMA are not always consistently followed and studies are stopped prematurely after only interim analysis that at this time point shows improved efficacy with regard to the comparator arm. Our current analysis of the European Assessment Reports (reporting period: 01/01/2009 to 08/13/2012) on 29 drugs for 39 oncology indications shows that the quality of the trials for market authorisation has improved in several respects. Primary endpoints recommended by the EMA and the Food and Drug Administration (FDA) such as overall survival and progression-free survival are used, and only one study was conducted as a phase II trial with no comparator arm. In contrast, oncology drugs that are approved for the treatment of rare diseases (orphan drugs) are based on small studies which are often carried out without blinding, are not randomised and investigate surrogate endpoints. To answer patient-relevant issues following market authorisation, it is necessary to conduct independent clinical studies. Increased public funding needs to be provided and bureaucratic hurdles have to be reduced. Only this will permit a more efficient use of limited health care resources and allow to improve the quality of care for cancer patients. Copyright © 2013 S. Karger AG, Basel.

Treatment for gender dysphoria in children: the new legal, ethical and clinical landscape.

PubMed

Smith, Malcolm K; Mathews, Ben

2015-02-02

Gender dysphoria is a condition in which a child's subjectively felt identity and gender are not congruent with her or his biological sex. Because of this, the child suffers clinically significant distress or impairment in social functioning. The Family Court of Australia has recently received an increasing number of applications seeking authorisation for the provision of hormones to treat gender dysphoria in children. Some medical procedures and interventions performed on children are of such a grave nature that court authorisation must be obtained to render them lawful. These procedures are referred to as special medical procedures. Hormonal therapy for the treatment of gender dysphoria in children is provided in two stages occurring years apart. Until recently, both stages of treatment were regarded by courts as special medical treatments, meaning court authorisation had to be provided for both stages. In a significant recent development, courts have drawn a distinction between the two stages of treatment, permitting parents to consent to the first stage. In addition, it has been held that a child who is determined by a court to be Gillick competent can consent to stage 2 treatment. The new legal developments concerning treatment for gender dysphoria are of ethical, clinical and practical importance to children and their families, and to medical practitioners treating children with gender dysphoria. Medical practitioners should benefit from an understanding of the recent developments in legal principles. This will ensure that they have up-to-date information about the circumstances under which treatment may be conducted with parental consent, and those in which they must seek court authorisation.

Conflict of interest in biomedical research: a view from Europe.

PubMed

Salvi, Maurizio

2003-01-01

In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address CoI in the authorisation process of research and clinical protocols of biomedicine.

Economic Evaluations of Pharmaceuticals Granted a Marketing Authorisation Without the Results of Randomised Trials: A Systematic Review and Taxonomy.

PubMed

Hatswell, Anthony J; Freemantle, Nick; Baio, Gianluca

2017-02-01

Pharmaceuticals are usually granted a marketing authorisation on the basis of randomised controlled trials (RCTs). Occasionally the efficacy of a treatment is assessed without a randomised comparator group (either active or placebo). To identify and develop a taxonomic account of economic modelling approaches for pharmaceuticals licensed without RCT data. We searched PubMed, the websites of UK health technology assessment bodies and the International Society for Pharmacoeconomics and Outcomes Research Scientific Presentations Database for assessments of treatments granted a marketing authorisation by the US Food and Drug Administration or European Medicines Agency from January 1999 to May 2014 without RCT data (74 indications). The outcome of interest was the approach to modelling efficacy data. Fifty-one unique models were identified in 29 peer-reviewed articles, 30 health technology appraisals, and 15 International Society for Pharmacoeconomics and Outcomes Research abstracts concerning 30 indications (44 indications had not been modelled). We noted the high rate of non-submission to health technology assessment agencies (28/98). The majority of models (43/51) were based on 'historical controls'-comparisons to previous meta-analysis or pooling of trials (5), individual trials (16), registries/case series (15), or expert opinion (7). Other approaches used the patient as their own control, performed threshold analysis, assumed time on treatment was added to overall survival, or performed cost-minimisation analysis. There is considerable variation in the quality and approach of models constructed for drugs granted a marketing authorisation without a RCT. The most common approach is of a naive comparison to historical data (using other trials/registry data as a control group), which has considerable scope for bias.

Task Delegation Based Access Control Models for Workflow Systems

NASA Astrophysics Data System (ADS)

Gaaloul, Khaled; Charoy, François

e-Government organisations are facilitated and conducted using workflow management systems. Role-based access control (RBAC) is recognised as an efficient access control model for large organisations. The application of RBAC in workflow systems cannot, however, grant permissions to users dynamically while business processes are being executed. We currently observe a move away from predefined strict workflow modelling towards approaches supporting flexibility on the organisational level. One specific approach is that of task delegation. Task delegation is a mechanism that supports organisational flexibility, and ensures delegation of authority in access control systems. In this paper, we propose a Task-oriented Access Control (TAC) model based on RBAC to address these requirements. We aim to reason about task from organisational perspectives and resources perspectives to analyse and specify authorisation constraints. Moreover, we present a fine grained access control protocol to support delegation based on the TAC model.

European regulatory use and impact of subgroup evaluation in marketing authorisation applications.

PubMed

Tanniou, Julien; Teerenstra, Steven; Hassan, Sagal; Elferink, Andre; van der Tweel, Ingeborg; Gispen-de Wied, Christine; Roes, Kit C B

2017-12-01

Marketing authorisation application dossiers relating to medicinal products containing new active substances and evaluated by the European Medicines Agency (EMA) over the period 2012-2015 were examined. Major objections and other concerns relating to efficacy and safety of the day 80 assessment reports were reviewed. Overall, approved products have more subgroup concerns than nonapproved products, which seems to be a consistent pattern. Subgroup analyses are mainly assessed to have the insurance that subgroups of patients that might lack a positive benefit: risk ratio will not be wrongly included in the approved treatment indication. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Threshold Things That Think: Authorisation for Resharing

NASA Astrophysics Data System (ADS)

Peeters, Roel; Kohlweiss, Markulf; Preneel, Bart

As we are evolving towards ubiquitous computing, users carry an increasing number of mobile devices with sensitive information. The security of this information can be protected using threshold cryptography, in which secret computations are shared between multiple devices. Threshold cryptography can be made more robust by resharing protocols, which allow recovery from partial compromises. This paper introduces user-friendly and secure protocols for the authorisation of resharing protocols. We present both automatic and manual protocols, utilising a group manual authentication protocol to add a new device. We analyse the security of these protocols: our analysis considers permanent and temporary compromises, denial of service attacks and manual authentications errors of the user.

Spectroscopy applied to feed additives of the European Union Reference Laboratory: a valuable tool for traceability.

PubMed

Omar, Jone; Slowikowski, Boleslaw; Boix, Ana; von Holst, Christoph

2017-08-01

Feed additives need to be authorised to be placed on the market according to Regulation (EU) No. 1831/2003. Next to laying down the procedural requirements, the regulation creates the European Union Reference Laboratory for Feed Additives (EURL-FA) and requires that applicants send samples to the EURL-FA. Once authorised, the characteristics of the marketed feed additives should correspond to those deposited in the sample bank of the EURL-FA. For this purpose, the submitted samples were subjected to near-infrared (NIR) and Raman spectroscopy for spectral characterisation. These techniques have the valuable potential of characterising the feed additives in a non-destructive manner without any complicated sample preparation. This paper describes the capability of spectroscopy for a rapid characterisation of products to establish whether specific authorisation criteria are met. This study is based on the analysis of feed additive samples from different categories and functional groups, namely products containing (1) selenium, (2) zinc and manganese, (3) vitamins and (4) essential oils such as oregano and thyme oil. The use of chemometrics turned out to be crucial, especially in cases where the differentiation of spectra by visual inspection was very difficult.

Access and authorisation in a Glocal e-Health Policy context.

PubMed

Scott, Richard E; Jennett, Penny; Yeo, Maryann

2004-03-31

Challenges to the development of appropriate yet adaptable policy and tools for security of the individual patient electronic health record (EHR) are proving to be significant. Compounding this is the unique capability of e-health to transgress all existing geo-political and other barriers. Initiatives to develop and advance policy, standards, and tools in relation to EHR access control and authorisation management must address this capability. Currently policy development initiatives take place largely in an isolated manner. This jeopardises the potential of e-health because decisions made in one jurisdiction might hamper, even prevent, an e-health opportunity in another. This paper places access and authorisation issues in an overall policy context through describing current Canadian initiatives. The National Initiative for Telehealth (NIFTE) Guidelines project is developing a framework of national guidelines for telehealth. The Policy and Peer Permission (PPP) project is developing a unique tool that provides persistent protection of data. The new corporate body 'Infoway' is developing a pan-Canadian electronic health record solution. Finally, the Glocal e-Health Policy initiative is developing a tool with which to identify and describe the inter-relationships of e-health issues amongst policy levels, themes, and actors.

The contribution of neighbouring countries to pesticide levels in Dutch surface waters.

PubMed

Van 'T Zelfde, M; Tamis, W L M; Vijver, M G; De Snoo, G R

2011-01-01

Compared with other European countries, Dutch consumption of pesticides is high, particularly in agriculture, with many of the compounds found in surface waters in high concentrations and various standards being exceeded. Surface water quality is routinely monitored and the data obtained are published in the Dutch Pesticides Atlas. One important mechanism for reducing pesticide levels in surface waters is authorisation policy, which proceeds on the assumption that the pollution concerned has taken place in the Netherlands. The country straddles the delta of several major European rivers, however, and as river basins do not respect national borders some of the water quality problems will derive from neighbouring countries. Against this background the general question addressed in this article is the following: To what extent do countries neighbouring on the Netherlands contribute to pesticide pollution of Dutch surface waters? To answer this question, data from the Pesticides Atlas for the period 2005-2009 were used. Border zones with Belgium and Germany were defined and the data for these zones compared with Dutch data. In the analyses, due allowance was also made for authorised and non-authorised compounds and for differences between flowing and stagnant waters. Monitoring efforts in the border zones and in the Netherlands were also characterised, showing that efforts in the former are similar to those in the rest of the country. In the border zone with Belgium the relative number of non-authorised pesticides exceeding the standards is clearly higher than in the rest of the Netherlands. These exceedances are observed mainly in flowing waters. In contrast, there is no difference in the relative number of standard-exceeding measurements between the border zones and the rest of the Netherlands. In the boundary zones the array of standard-exceeding compounds clearly deviates from that in the rest of the Netherlands, with compounds authorised in the neighbouring countries but not in the Netherlands, such as flufenacet, featuring prominently. The share of the neighbouring countries in the total number of exceedances in the Netherlands is roughly proportional to the relative area of the border zones. Although there is a certain influx of pesticides from across national borders, the magnitude of the problem appears to be limited.

Unauthorised absences from leave from an Australian security hospital.

PubMed

Scott, Russ; Goel, Vikram; Neillie, Darren; Stedman, Terry; Meehan, Tom

2014-04-01

To consider incidents relating to absences without permission from authorised leave from a security hospital. A retrospective audit over a 10-year period of all critical incidents relating to leave from the High Security Inpatient Services, Brisbane, Australia. There has been a low incidence of patients absenting themselves without permission from leave. Of the 12 patients who went absent without permission over the 10-year study period, only one patient was reported to have committed an offence and no patient seriously self-harmed. Attention to patient selection and risk management strategies have been effective in minimising the risk to patients and to the community as a direct result of absences without permission from authorised leave.

Determinants for successful marketing authorisation of orphan medicinal products in the EU.

PubMed

Putzeist, Michelle; Heemstra, Harald E; Garcia, Jordi Llinares; Mantel-Teeuwisse, Aukje K; Gispen-De Wied, Christine C; Hoes, Arno W; Leufkens, Hubert G M

2012-04-01

In 2010, the European Regulation for Orphan Medicinal Products (OMPs) was in force for ten years. In this study we assessed possible determinants of applications for OMPs in the EU since 2000 that are associated with a successful marketing authorisation. Our analysis shows that clinical trial characteristics such as demonstrating convincing evidence of a beneficial effect on the primary endpoint, the selection of a clinically relevant endpoint, providing RCT data as pivotal study evidence and the submission of sound dose finding data are critical success factors. In addition, high medical need seems to counterweigh uncertainties about the scientific evidence in the benefit-risk assessment of OMPs. Copyright © 2011 Elsevier Ltd. All rights reserved.

Responsibilities of regulatory agencies in the marketing of antimicrobials.

PubMed

Grein, K

2012-04-01

The regulatory agencies' main responsibility regarding the marketing of veterinary medicinal products is to ensure that the products have a marketing authorisation with specific conditions of use adequate to ensure the quality, safety and efficacy of the product under consideration. In addition, control and surveillance systems are necessary to allow monitoring of the product after it has been authorised. In respectto antimicrobials, specific consideration must be given to minimising resistance development and retaining the effectiveness of these drugs for the treatment of humans and animals. Surveillance programmes should be in place to follow trends in resistance development, as well as in the consumption of veterinary antimicrobials, in order to provide for science-based policy recommendations regarding public and animal health.

Policies and availability of orphan medicines in outpatient care in 24 European countries.

PubMed

Sarnola, Kati; Ahonen, Riitta; Martikainen, Jaana E; Timonen, Johanna

2018-04-09

To assess pricing and reimbursement policies specific to orphan medicines and the availability and distribution settings of ten recently authorised medicinal products suitable for outpatient care with orphan status and centralised marketing authorisation in Europe, and whether patients receive these products free of charge or have to pay some or all of the costs themselves. Web survey to authorities and representatives of third party payers in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network in April 2016. In most of the 24 countries, special policies were not implemented in the assessment of reimbursement status (22 countries) or in the pricing (20 countries) of orphan medicines. An average of five of the ten recently authorised products per country were available for outpatient care. Products were dispensed from community pharmacies in eight countries and from health care units in five countries. In four countries, both distribution settings were used. When products were dispensed from community pharmacies, patients typically paid some of the price themselves. Products dispensed from health care units were often free of charge for patients. Most European countries had not implemented pricing and reimbursement policies specific to orphan medicines. The availability of orphan products varied between countries. It is important to discuss whether orphan medicines should be considered as a separate group in the reimbursement regulations in order to secure patient access to these medicines.

[Immunogenicity of biosimilars].

PubMed

van Aerts, L A G J M; Franken, A A M; Leufkens, H G M

2016-01-01

Biosimilars of more complex recombinant protein drugs, such as monoclonal antibodies and fusion proteins, are entering the market. The manufacturer should demonstrate that its product does not show any relevant differences in terms of quality characteristics, biological activity, safety and efficacy compared to the reference product, as outlined in EMA guidelines. This should be established with an extensive comparability exercise. One aspect that is subject to particular scrutiny is the immunogenicity of the biosimilar and the reference medicinal product. For three cases, one etanercept and two infliximab biosimilars, we describe how data are assessed and an opinion is reached by authorities. Not in all cases unanimity exists whether all remaining uncertainties on biosimilarity have been resolved satisfactorily before marketing authorisation. The Dutch Medicines Evaluation Board therefore emphasises that even after marketing authorisation, biosimilars and other biologicals should be properly monitored.

Olefins and chemical regulation in Europe: REACH.

PubMed

Penman, Mike; Banton, Marcy; Erler, Steffen; Moore, Nigel; Semmler, Klaus

2015-11-05

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the European Union's chemical regulation for the management of risk to human health and the environment (European Chemicals Agency, 2006). This regulation entered into force in June 2007 and required manufacturers and importers to register substances produced in annual quantities of 1000 tonnes or more by December 2010, with further deadlines for lower tonnages in 2013 and 2018. Depending on the type of registration, required information included the substance's identification, the hazards of the substance, the potential exposure arising from the manufacture or import, the identified uses of the substance, and the operational conditions and risk management measures applied or recommended to downstream users. Among the content developed to support this information were Derived No-Effect Levels or Derived Minimal Effect Levels (DNELs/DMELs) for human health hazard assessment, Predicted No Effect Concentrations (PNECs) for environmental hazard assessment, and exposure scenarios for exposure and risk assessment. Once registered, substances may undergo evaluation by the European Chemicals Agency (ECHA) or Member State authorities and be subject to requests for additional information or testing as well as additional risk reduction measures. To manage the REACH registration and related activities for the European olefins and aromatics industry, the Lower Olefins and Aromatics REACH Consortium was formed in 2008 with administrative and technical support provided by Penman Consulting. A total of 135 substances are managed by this group including 26 individual chemical registrations (e.g. benzene, 1,3-butadiene) and 13 categories consisting of 5-26 substances. This presentation will describe the content of selected registrations prepared for 2010 in addition to the significant post-2010 activities. Beyond REACH, content of the registrations may also be relevant to other European activities, for example consideration of worker DNELs/DMELs for occupational exposure level setting, discussion of this aspect will be presented for 1,3-butadiene. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Applications of AOPs to ecotoxicology

EPA Science Inventory

Toxicologists conducting safety assessments for either human or ecological health are responsible for generating data for possible adverse effects of a rapidly increasing number of substances. For example, the Registration, Evaluation, Authorisation and Restriction of Chemicals (...

OUTSOURCING ETHICAL DILEMMAS: REGULATING INTERNATIONAL SURROGACY ARRANGEMENTS.

PubMed

Fenton-Glynn, Claire

2016-01-01

This article argues that the English legislative regime is ineffective in regulating international surrogacy, particularly with regard to commercial payments. It suggests that if English law views surrogacy as exploitative, we have a responsibility to protect women both in England and abroad, and the only way to do so effectively is to create a domestic system of regulation that caters adequately for the demand in this country. This requires a system of authorisation for surrogacy before it is undertaken; ex-post facto examinations of agreements completed in other jurisdictions, after the child is already living with the commissioning parents, cannot be seen as an acceptable compromise, as authorisation will inevitably be granted in the child's best interests. © The Author 2016. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.

Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance.

PubMed

Permanand, Govin; Mossialos, Elias; McKee, Martin

2006-01-01

Following a review process lasting almost four years, and culminating in several pieces of new European legislation, adjustments have been made to the European Union's (EU) regulatory framework for pharmaceuticals. The European Commission laid out its priorities for the review as: simplifying the authorisation system, ensuring a high quality of public health, completing the internal market in medicines, and preparing for the enlargement of the Union. Amongst the most important changes brought about by the new rules are those relating to the European drug approval procedures, the functions and operational transparency of the European Medicines Agency (EMEA), and the EU's pharmacovigilance system. This article provides a brief examination of key elements of these changes, and considers the extent to which they serve the goal of improved public health protection within the EU.

US Army Corps of Engineers Section 404: permitting of valley fills - red flag or red tape?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thomas R. Johnston, Jr.

2009-03-15

Since 2001 the US Army Corps of Engineers has been permitting most surface coal mines as Individual Permits rather than Nationwide Permits under the Section 404 program. This was shown in a survey by Skelly & Loy of permits published by Huntingdon Crops District and the state of Kentucky. Nationwide Permit 21 (NWP21) authorises the filling of waters of the United States associated with surface coal mining and reclamation operations already authorised or currently being processed as part of the integrated permit processing procedure. NWP21 has received much opposition and two noticeable court cases involving it, in West Virginia andmore » Kentucy, are briefly reported. The article first appeared in Skelly & Loy's newsletter, Portal to the mining industry, Vol II, Issue 1. 4 photos.« less

[Marketing approval and market surveillance of medical devices in Germany: Where does policy integration take place?].

PubMed

Lang, Achim

2014-01-01

Since 2011 new regulatory measures regarding medical devices have been set up with the aim to eliminate obstacles to innovations and to find more coordinated ways to marketing authorisation and market surveillance. This essay investigates whether these new and existing coordination mechanisms build up to a Joined-up Government approach. The analysis shows that the regulatory process should be adjusted along several dimensions. First, many organisations lack awareness regarding their stakeholders and focus solely on their immediate organisational activities. Second, the regulatory process (marketing authorisation and market surveillance) is too fragmented for an effective communication to take place. Finally, the underlying strategy process is an ad-hoc approach lacking continuity and continued involvement of, in particular, the responsible federal ministries. Copyright © 2013. Published by Elsevier GmbH.

Should Anthroposophic Medicinal Products Be Regulated in Europe?

PubMed

Michaux, Geneviève

2017-03-01

European Commission’s reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market. Such access can result from specific rules on anthroposophic products, but can be more efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.

Requirements for authorisation of internal dosimetry services.

PubMed

Melo, D R; Cunha, P G; Torres, M M C; Lourenço, M C

2003-01-01

In order to ensure that a facility is in compliance with the occupational exposure requirements established by regulatory authorities, the measurements and dose assessments specified in the individual monitoring programme need to be reliable. There are two important questions that shall be addressed here: one is how the licensed facilities can demonstrate to their workers and regulatory bodies compliance with the regulatory limits and the reliability of the results of the individual monitoring programmes; the other concerns the mechanisms used to demonstrate to a facility in another country the reliability of the measurement results of an individual monitoring bioassay programme. The accreditation of the bioassay laboratory, according to ISO/IEC 17025, shall be the basic requirement for obtaining the authorisation granted by the national regulatory authority. For the second question, such confidence can be achieved through International Laboratory Accreditation Cooperation (ILAC).

Authority, autonomy, responsibility and authorisation: with specific reference to adolescent mental health practice.

PubMed Central

Sutton, A

1997-01-01

Standards for professional training and practice are defined by accrediting organisations or statutory bodies. These describe the arena in which the practitioner may speak with authority. The sphere of authorised practice is further delineated by the external resources available. Within this explicit framework, unconscious mental processes can affect the professional response in potentially adverse ways. This is particularly important in mental health practice. Professionals must be prepared to examine their own responses on this basis in order to enhance their knowledge of the patient and minimise the possibilities of the patient becoming the victim of the professional's own psychopathology. The maintenance of such a position in an institution or organisation requires a similar process within its structure in order to provide the necessary setting and define the limits of good practice. In this paper, the field of adolescent mental health is specifically examined. PMID:9055159

Best practicable means (BPM) and as low as reasonably practicable (ALARP) in action at Sellafield.

PubMed

Morley, Bob

2004-03-01

Operators within the UK nuclear industry are required to employ 'best practicable means' (BPM) to control and minimise radioactive discharges. The requirement for the use of BPM is in order to ensure that doses from discharges are as low as reasonably practicable (ALARP). This facet is increasingly becoming the principal feature of discharge authorisations issued by the Environment Agencies under the Radioactive Substances Act, 1993 (RSA 93), which are enforceable by law. It is important to state at the outset, however, that scientific assessments to date indicate that there are no expectations of environmental harm from authorised discharges, even where those discharges have historically been up to two orders of magnitude higher than current levels. There is also no evidence to indicate that foreseeable future discharges from the Sellafield site will make any contribution to environmental harm.

[The role of the Committee for Medicinal Products for Human Use (CHMP) in the European centralised procedure].

PubMed

Enzmann, Harald; Schneider, C

2008-07-01

The centralised procedure for marketing authorisation at the European Medicines Agency (EMEA) started more than 10 years ago, offering marketing authorisation for all member states of the European Union in a single procedure. Originally it was a purely optional alternative to the established national procedures; however, its importance has been growing ever since. The introduction of the mandatory scope for several important indications was a crucial step. The increasing importance of the centralised procedure was paralleled by the increasing weight of the EMEA and of the Committee for Human Medicinal Products (CHMP) who is responsible for scientific evaluation in the centralised procedure. This paper describes the basic principles of the centralised procedure including the definitions of the mandatory and optional scope, and how the CHMP works including its responsibility in European referrals that provide a link to national procedures.

[Food, health claims and drugs. Conclusions - recommendations. The National Academy of Pharmacy].

PubMed

Bourlioux, P

2008-01-01

Even if the activity of health claim foods is not relevant to the activity of drugs, we are just at the frontier of two fields which needs the greatest attention. Since foods and drugs are present in the same domain of prevention, the French Academy of Pharmacy draws attention on the necessary relevant and scientifically proven demonstration of the health claims using the same quality standard than those used for drugs (good clinical practises, methodologies correspondent to the current requirement, etc.). It is why the Academy wishes to express five recommendations fearing that the risks of confusion and abuse prevail on the possibilities of information and control. Make sure that foods are not mistaken with drugs; largely spread the lists of authorised claims; introduce the new notion of "nutrivigilance"; make sure that the only authorised health claims use advertising; reject the terms "alicaments" and "nutraceuticals" which are confusing with drugs.

The importance of regulatory data protection or exclusive use and other forms of intellectual property rights in the crop protection industry.

PubMed

Carroll, Michael J

2016-09-01

In order for a chemical plant protection product to be authorised for sale a registration dossier has to be assembled to demonstrate safety and efficacy to the satisfaction of government regulators. These studies and tests are protected for a period of 10 years in Europe, North America and some other jurisdictions from the date of first product authorisation so that only the data owner can gain commercial benefit from the data. Subsequent regulatory reviews which require new studies should not result in further periods of regulatory data protection exclusive use for the new data but compensation should be payable to the data generator. © 2016 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry. © 2016 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

Pesticide exposure assessment for surface waters in the EU. Part 2: Determination of statistically based run-off and drainage scenarios for Germany.

PubMed

Bach, Martin; Diesner, Mirjam; Großmann, Dietlinde; Guerniche, Djamal; Hommen, Udo; Klein, Michael; Kubiak, Roland; Müller, Alexandra; Preuss, Thomas G; Priegnitz, Jan; Reichenberger, Stefan; Thomas, Kai; Trapp, Matthias

2017-05-01

In order to assess surface water exposure to active substances of plant protection products (PPPs) in the European Union (EU), the FOCUS (FOrum for the Co-ordination of pesticide fate models and their USe) surface water workgroup introduced four run-off and six drainage scenarios for Step 3 of the tiered FOCUSsw approach. These scenarios may not necessarily represent realistic worst-case situations for the different Member States of the EU. Hence, the suitability of the scenarios for risk assessment in the national authorisation procedures is not known. Using Germany as an example, the paper illustrates how national soil-climate scenarios can be developed to model entries of active substances into surface waters from run-off and erosion (using the model PRZM) and from drainage (using the model MACRO). In the authorisation procedure for PPPs on Member State level, such soil-climate scenarios can be used to determine exposure endpoints with a defined overall percentile. The approach allows the development of national specific soil-climate scenarios and to calculate percentile-based exposure endpoints. The scenarios have been integrated into a software tool analogous to FOCUS-SWASH which can be used in the future to assess surface water exposure in authorisation procedures of PPPs in Germany. © 2017 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry. © 2017 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products.

PubMed

Lucas-Samuel, Sophie; Ferry, Nicolas; Trouvin, Jean-Hugues

2015-01-01

Advanced therapy medicinal products, a new class of products with promising therapeutic effects, have been classified as medicinal products and as such should be developed according to a well-structured development plan, to establish their quality, safety and efficacy profile and conclude, at the time of the marketing authorisation evaluation, on a positive risk/benefit balance for patients. An important part of this development plan is achieved through clinical trials, which have also to be approved according to a well-established regulatory process, prior any initiation. This chapter is dedicated to describe the regulatory pathway to be followed in France, before initiating any clinical trial with those investigational advanced therapy medicinal products. In France, to get the final authorisation to initiate a clinical trial, the legislation imposes to run in parallel two independent but complementary authorisation procedures. The first procedure is aimed at assessing the ethical aspect of the biomedical research, while the second has to review the safety and regulatory aspects. A third procedure has to be envisaged where in case the investigational product consists or contains a genetically modified organism. The French system herein described is in line with the EU regulation on clinical trial and follows the respective deadlines for granting the final approval. The complexity of the procedure is in fact more due to the complexity of the products and protocols to be assessed than to the procedure itself which is now very close to the well-known procedure applied routinely for more conventional chemical or biological candidate medicinal products.

Administrative complexities for a European observational study despite directives harmonising requirements.

PubMed

Gülmez, Sinem Ezgi; Lignot-Maleyran, Séverine; de Vries, Corinne S; Sturkenboom, Miriam; Micon, Sophie; Hamoud, Fatima; Blin, Patrick; Moore, Nicholas

2012-08-01

For pharmacoepidemiological studies in Europe, accessing data should require only authorisation by the relevant data protections committees, as expected from the 1995 Data Protection Directive (95/46/EC). Our experience from a multinational observational study across seven European countries shows that this is certainly not the case. The study was a multicentre, multinational, case-population study in European liver transplant centres in seven countries, retrospectively evaluating a 3-year period. Before data collection started, the procedures to obtain the necessary authorisations for the participating countries were defined. In France, a single opinion from a single data protection committee was enough to start the study. In Italy, Portugal, Greece and the UK, there was a national authority, but the hospitals requested the approval by their local committees/bodies irrespective of whether the authorisation of the national committee came after or before that of local ones. In Ireland, only one hospital participated, and the opinion of its ethics committee was sufficient. In the Netherlands, the opinion of the institutional review board of the local coordinating centre was necessary to obtain the opinions from the institutional review boards of the other hospitals. The information requested by the different committees and the time to obtain the approvals varied, even within the same country. This degree of complexity and disharmony, and resulting cost, was observed in a simple retrospective study. Regulators will need to be aware that these time-consuming, expensive and useless complexities must be factored in when estimating the time and cost of a study. Copyright © 2012 John Wiley & Sons, Ltd.

Engineering Technical Support Center Annual Report Fiscal Year 2015

EPA Science Inventory

The United States Environmental Protection Agency (EPA or Agency) Office of Research and Development (ORD) created the Engineering Technical Support Center (ETSC) in 1987, one of several technical support centers created as part of the Technical Support Project (TSP). ETSC provid...

Evaluation of the ’Mentor’ Assessment and Feedback System for Air Battle Management Team Training

DTIC Science & Technology

2006-11-01

authorised properly All aircraft entering ADIZ are identified in a timely manner Challenge procedures issued Unauthorised aircraft...maintained Effective low-level sanitisation Tactical Employment Pre-emptive Inter-FEZ Co- ordination Authentication procedures enforced

Technical Support for Contaminated Sites | Science Inventory ...

EPA Pesticide Factsheets

In 1987, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD), Office of Land and Emergency Management, and EPA Regional waste management offices established the Technical Support Project. The creation of the Technical Support Project enabled ORD to provide effective technical assistance by ensuring ORD scientists and engineers were accessible to the Agency’s Office and Regional decision makers, including Remedial Project Managers, On-Scene Coordinators, and corrective action staff. Five ORD Technical Support Centers (TSCs) were created to facilitate this technical assistance. Three of the five TSCs are supported by the Sustainable and Healthy Communities Research Program, and are summarized in the poster being presented:• Engineering Technical Support Center (ETSC) in Cincinnati, Ohio• Ground Water Technical Support Center (GWTSC) in Ada, Oklahoma• Site Characterization and Monitoring Technical Support Center (SCMTSC) in Atlanta, GeorgiaOver the past 29 years, the Technical Support Centers have provided numerous influential products to its internal Agency clients and to those at the State level (through the EPA Regions). These products include, but are not limited to the following: Annual TSC reports from the three Centers, a hard-rock mining conference every other year, PRO-UCL software development for site characterization statistics, groundwater modeling using state-of-the-art modeling software, numerical mo

ORD Scientific and Engineering Technical Support for RPMs – Ground Water Technical Support Center

EPA Science Inventory

ORD Scientific and Engineering Technical Support for RPMs (and Others) is a hybrid informational and panel session that focuses on the technical support available from EPA’s Office of Research and Development (ORD) to RPMs and other EPA cleanup program staff. Examples of technica...

How to improve the clinical development paradigm and its division into phases I, II and III.

PubMed

Bamberger, Marion; Moore, Nicholas; Lechat, Philippe

2011-01-01

Based on the observation that over the last 30 years the cost of development has risen regularly as the number of new chemical entities reaching the market has fallen, how can "savings" be made in terms of clinical development, the objective being more rapid access to a drug for medical needs that are not covered? Several instruments exist to enable innovative products to be made available more quickly: temporary use authorisations, which are not concerned by this work (ATUs), conditional marketing authorisations (MAs) and MAs under exceptional circumstances. These aspects have been taken up in the European medicines agency (EMA)'s "Road Map", which states "A key issue for Regulators will be if a more "staggered" approval should be envisaged, characterised by a better defined/more restricted population of good responders, followed by a broadening of the population post-authorisation when more "real life" data are available. In addition, maximising the value of information generated in the post-authorisation phase should be developed through the use of cohorts and other prospectively collected use data, especially in the case of conditional marketing authorisations." The rules of procedure of the Transparency Commission for their part provide for the notion of preliminary examination: in order to prepare as best as possible the examination of dossiers of products assumed to be innovative and to limit delays, the office can undertake a preliminary study as soon as the dossier has been filed at the Committee for medicinal products for human use (CHMP). It may, at this time, request the firm to provide further information and may call on external experts. The implementation of this preliminary study does not exonerate the firm of the obligation of filing a complete dossier. The post inscription studies requested by the Transparency Commission (ISPEP - public health benefit and post-marketing studies) are usually requested in the case of hesitations regarding the level of improvement of the medical benefit (ASMR) [level II/III or IV/V]. Such requests mainly concern uncertainties regarding the transposability, the patient profile or correct usage in real life. Among the studies whose results were provided, in 15 cases the results were in line with expectations, in 6 cases they resulted in downward re-evaluations and the final 3 cases were inconclusive. The final recommendations of the round table were: Defining the medical need that is not covered by working in consultation (Industry and Health Authorities); Providing a Complementary Investigations Plan (PIC) after the MA at a very early stage to reinforce the early MA, and/or HTA (health technology assessment) preparation and monitoring (possible constraining actions); Enhanced use of modelling techniques and their transposability; "Intussusception" of phases to optimise the development of a complete dossier; Early "scientific opinions" (EMA, French Health Products Safety Agency [Afssaps], French Health Authority [HAS]); Raising the awareness of the authorities, industry, doctors and patients with regard to controlled observational studies; Developing the use of public data bases. © 2011 Société Française de Pharmacologie et de Thérapeutique.

Chief medical officer actions on information security in an Italian rehabilitation centre.

PubMed

Reni, Gianluigi; Molteni, Massimo; Arlotti, Stefano; Pinciroli, Francesco

2004-03-31

In a multi-speciality rehabilitation centre, where child neuropsychiatrists, neurologists, physical rehabilitators, psychologists, nurses, therapists and other health care professionals actively care for patients, the moment will arrive when information security takes high priority on the chief medical officer (CMO) agenda. This has happened at the La Nostra Famiglia Institution. Local push to high priority arose from several concurrent forces, like privacy both on the patient and on the doctor side, legal and ethical aspects. Recommendations on the protection of medical data require appropriate technical and organisational measures to be taken to protect personal data against unauthorised access, alterations or any other form of inappropriate processing. In the same time quick and easy access to patient information should be granted to authorised personnel to ensure proper and in time treatment of patients. A long lasting sequence of co-operative negotiation meetings between the CMO and the chief information officer (CIO) led to appropriate outline of policies. We developed a suitable and modular architecture for designing systems that can simultaneously manage an increasing number of healthcare actors, objects and related access levels taking into account temporal conditions. Actions for keeping the prototype in use on an everyday basis are directly taken by the CMO.

Obtaining Technical Support for Superfund, RCRA and Brownfields Site Issues Fact Sheet

EPA Pesticide Factsheets

EPA’s Technical Support Centers (TSCs) and other technical support services are available to Regional RemedialProject Managers, Corrective Action Staff, and On-Scene Coordinators needing specialized technical expertisefor specific tasks or projects.

Fluor Hanford, Inc. Groundwater and Technical Integration Support (Master Project) Quality Assurance Management Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fix, N. J.

The scope of the Fluor Hanford, Inc. Groundwater and Technical Integration Support (Master Project) is to provide technical and integration support to Fluor Hanford, Inc., including operable unit investigations at 300-FF-5 and other groundwater operable units, strategic integration, technical integration and assessments, remediation decision support, and science and technology. This Quality Assurance Management Plan provides the quality assurance requirements and processes that will be followed by the Fluor Hanford, Inc. Groundwater and Technical Integration Support (Master Project).

REACH – an overview

PubMed Central

Čihák, Rostislav

2009-01-01

An outline of the new European policy in the management of chemicals is given. This new system is known under the acronym REACH which stands for Registration, Evaluation and Authorisation of Chemicals. The background, objectives, requirements and the operation of REACH are briefly explained. PMID:21217844

78 FR 70586 - Technical Support Document: Technical Update of the Social Cost of Carbon for Regulatory Impact...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-26

... OFFICE OF MANAGEMENT AND BUDGET Technical Support Document: Technical Update of the Social Cost of... Budget, Executive Office of the President. ACTION: Notice of availability and request for comments. SUMMARY: The Office of Management and Budget (OMB) requests comments on the Technical Support Document...

Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments.

PubMed

Wild, Claudia; Erdös, Judit; Zechmeister, Ingrid

2014-11-04

European medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits of new cardio-vascular devices. Since no information is available on clinical data used by the Notified Body for CE-marking, data from Austrian pre-reimbursement assessments close to European market approval were used as proxy and compared with clinical data available at time of market approval by FDA in the USA. 10 cardio-vascular interventions with 27 newly CE approved medical devices were analysed. The time lag between market authorisation in Europe and in the USA is 3 to 7 years. Only 7 CE-marked devices also hold a FDA market approval, 7 further devices are in FDA approved ongoing efficacy trials. For 4 of the CE-marked devices the FDA market application or the approval-trial was either suspended due to efficacy or safety concerns or the approval was denied. Evidence available at time of CE-marking are most often case-series or small feasibility RCTs, while large RCTs and only in rare cases prospective cohort studies are the basis of FDA approvals. Additionally, the FDA often requires post-approval studies for high-risk devices. Market authorisation based on mature clinical data deriving from larger RCTs and longer follow-ups do not only change the perspective on the risk-benefit ratio, but also secures real patient benefit and safety and assures payers of investing only in truly innovative devices.

Authorising bortezomib treatment prior to reviewing haematology results: a step toward home administration.

PubMed

Waight, Clinton C; Cain, Rebecca

2014-10-01

Bortezomib treatment requires four visits to a chemotherapy unit in each 21-day cycle. Analysis of the Day 1 full blood count could allow clinicians to predict the risk of Grade 4 thrombocytopenia, thus negating the need to review the full blood count prior to each dose. The freedom to administer bortezomib without reviewing full blood count results on each treatment day could minimise appointment times and be a step toward home administration. A prospective study of treatment authorisation following a full toxicity assessment and full blood count results from the previous treatment day was undertaken. The full blood count results from 27 patients, receiving 381 doses revealed 12 treatment episodes where bortezomib was administered in the presence of Grade 4 thrombocytopenia. One instance of bleeding and two episodes of neutropenic sepsis were detected during toxicity assessments and treatment was not administered. Only one instance of Grade 4 thrombocytopenia was reported on any other treatment day when the Day 1 platelet count was greater than 75 × 10(9) units/l. From this data, Day 1 full blood count parameters were derived, which minimise the risk of Grade 4 haematological toxicity on subsequent treatment days, allowing clinicians to identify suitable patients for administration of bortezomib prior to reviewing full blood count results. When platelet counts on Day 1 are greater than 75 × 10(9) units/l and neutrophil counts are greater than 1.0 × 10(9) units/l, the administration of bortezomib can be authorised without the need for review of the full blood count on subsequent days of that cycle. © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Determinants of utilisation differences for cancer medicines in Belgium, Scotland and Sweden.

PubMed

Ferrario, Alessandra

2017-12-01

Little comparative evidence is available on utilisation of cancer medicines in different countries and its determinants. The aim of this study was to develop a statistical model to test the correlation between utilisation and possible determinants in selected European countries. A sample of 31 medicines for cancer treatment that obtained EU-wide marketing authorisation between 2000 and 2012 was selected. Annual data on medicines' utilisation covering the in- and out-patient public sectors were obtained from national authorities between 2008 and 2013. Possible determinants of utilisation were extracted from HTA reports and complemented by contacts with key informants. A longitudinal mixed effect model was fitted to test possible determinants of medicines utilisation in Belgium, Scotland and Sweden. In the all-country model, the number of indications reimbursed positively correlated with increased consumption of medicines [one indication 2.6, 95% CI (1.8-3.6); two indications 2.4, 95% CI (1.4-4.3); three indications 4.9, 95% CI (2.2-10.9); all P < 0.01], years since EU-wide marketing authorisation [1.2, 95% CI (1.02-1.4); p < 0.05], price per DDD [0.9, 95% CI (0.998-0.999), P < 0.01], and Prescrire rating [0.5, 95% CI (0.3-0.9), P < 0.05] after adjusting for time and other covariates. In this study, the most important correlates of increased utilisation in a sample of cancer medicines introduced in the past 15 years were: medicines coverage and time since marketing authorisation. Prices had a negative effect on consumption in Belgium and Sweden. The positive impact of financial MEAs in Scotland suggests that the latter may remove the regressive effect of list prices on consumption.

Optimised padlock probe ligation and microarray detection of multiple (non-authorised) GMOs in a single reaction

PubMed Central

Prins, Theo W; van Dijk, Jeroen P; Beenen, Henriek G; Van Hoef, AM Angeline; Voorhuijzen, Marleen M; Schoen, Cor D; Aarts, Henk JM; Kok, Esther J

2008-01-01

Background To maintain EU GMO regulations, producers of new GM crop varieties need to supply an event-specific method for the new variety. As a result methods are nowadays available for EU-authorised genetically modified organisms (GMOs), but only to a limited extent for EU-non-authorised GMOs (NAGs). In the last decade the diversity of genetically modified (GM) ingredients in food and feed has increased significantly. As a result of this increase GMO laboratories currently need to apply many different methods to establish to potential presence of NAGs in raw materials and complex derived products. Results In this paper we present an innovative method for detecting (approved) GMOs as well as the potential presence of NAGs in complex DNA samples containing different crop species. An optimised protocol has been developed for padlock probe ligation in combination with microarray detection (PPLMD) that can easily be scaled up. Linear padlock probes targeted against GMO-events, -elements and -species have been developed that can hybridise to their genomic target DNA and are visualised using microarray hybridisation. In a tenplex PPLMD experiment, different genomic targets in Roundup-Ready soya, MON1445 cotton and Bt176 maize were detected down to at least 1%. In single experiments, the targets were detected down to 0.1%, i.e. comparable to standard qPCR. Conclusion Compared to currently available methods this is a significant step forward towards multiplex detection in complex raw materials and derived products. It is shown that the PPLMD approach is suitable for large-scale detection of GMOs in real-life samples and provides the possibility to detect and/or identify NAGs that would otherwise remain undetected. PMID:19055784

Optimised padlock probe ligation and microarray detection of multiple (non-authorised) GMOs in a single reaction.

PubMed

Prins, Theo W; van Dijk, Jeroen P; Beenen, Henriek G; Van Hoef, Am Angeline; Voorhuijzen, Marleen M; Schoen, Cor D; Aarts, Henk J M; Kok, Esther J

2008-12-04

To maintain EU GMO regulations, producers of new GM crop varieties need to supply an event-specific method for the new variety. As a result methods are nowadays available for EU-authorised genetically modified organisms (GMOs), but only to a limited extent for EU-non-authorised GMOs (NAGs). In the last decade the diversity of genetically modified (GM) ingredients in food and feed has increased significantly. As a result of this increase GMO laboratories currently need to apply many different methods to establish to potential presence of NAGs in raw materials and complex derived products. In this paper we present an innovative method for detecting (approved) GMOs as well as the potential presence of NAGs in complex DNA samples containing different crop species. An optimised protocol has been developed for padlock probe ligation in combination with microarray detection (PPLMD) that can easily be scaled up. Linear padlock probes targeted against GMO-events, -elements and -species have been developed that can hybridise to their genomic target DNA and are visualised using microarray hybridisation.In a tenplex PPLMD experiment, different genomic targets in Roundup-Ready soya, MON1445 cotton and Bt176 maize were detected down to at least 1%. In single experiments, the targets were detected down to 0.1%, i.e. comparable to standard qPCR. Compared to currently available methods this is a significant step forward towards multiplex detection in complex raw materials and derived products. It is shown that the PPLMD approach is suitable for large-scale detection of GMOs in real-life samples and provides the possibility to detect and/or identify NAGs that would otherwise remain undetected.

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

PubMed

Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

2015-01-01

In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

Legal and organisational innovation in the Italian pharmacy system: commercial vs public interest.

PubMed

Santuari, Alceste

2017-10-01

Pharmacy services are undoubtedly an important part of primary care. Pharmacists are entrepreneurs and simultaneously they are entrusted with a public mission in the health care sector. Pharmacies then reflect a contrast between a commercial/economic objective and public interest, which is to be identified with citizens' universal right to health care services. This is the reason why in Italy, as in many other EU countries, pharmacies supply their services according to a prior authorisation granted by public authorities. In common with many EU countries, this authorisation is secured according to a demographic criterion. It is only by means of these licensed pharmacies that citizens can buy drugs under medical prescription. Accordingly, the health system is to be driven by public interest, which has yet to prove how competing interests may be regulated in serving health needs. In the light of EU law, the article advocates for an innovative legal and organisational tool whereby to organise the Italian pharmacy system in order to combine economic consideration and public benefit.

Managing ethically questionable parental requests: growth suppression and manipulation of puberty.

PubMed

Isaacs, David; Tobin, Bernadette; Hamblin, Julie; Slaytor, Emma; Donaghue, Kim C; Munns, Craig; Kilham, Henry A

2011-09-01

Doctors sometimes struggle with ethically challenging requests for treatment from children's parents. For instance, we have recently had two requests by parents of children, a girl and a boy, each with a severe developmental disability, for hormonal therapy to suppress growth and puberty: the girl's parents requested, in addition, hysterectomy and mastectomy. We propose a reliable approach to assessing the ethical and legal aspects of these and other requests for 'non-therapeutic' treatment of a minor who lacks the capacity to give informed consent. We argue that a doctor should first assess whether the request is one that he or she can, in conscience, accede to, and then, if it is, seek the authorisation of a court. We outline considerations relevant to the doctor's assessment of both the ethical issues and to the need for court authorisation. © 2011 The Authors. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

EPA Technical Support Centers (TSC): FY14 Lessons ...

EPA Pesticide Factsheets

EPA’s Technical Support Centers (TSC) included in ORD’s Safe and Healthy Communities (SHC) Research Action Plan fill the need for supplying subject-matter experts to continually assess state-of-the-art research and practices and channel this information to users in both direct applications (i.e., site-specific technical support) and general applications (i.e., technical transfer activities such as technical guidance documents, conferences, or workshops) . The TSCs are charged with providing solutions by: 1) linking EPA research to Agency decision-makers; 2) applying best practices to real world field applications; and 3) channeling feedback from field application to research communities. The TSP goal is to provide Regional Remedial Project Managers (RPMs), Corrective Action Staff, and On-Scene Coordinators (OSCs) with a diverse set of readily-accessible resources for technical assistance. This research summary provides six case studies – two from each of the three TSCs (Ground Water Technical Support Center, Engineering Technical Support Center, and Site Characterization Technical Support Center) – to exemplify and summarize the variety of TSC approaches that contribute to fulfilling the TSP mission. EPA’s Technical Support Centers (TSC) included in ORD’s Safe and Healthy Communities (SHC) Research Action Plan fill the need for supplying subject-matter experts to continually assess state-of-the-art research and practices and channel this informati

Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

PubMed

Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory acceptance of 3R testing approaches, including a process for collection of real-life data (safe harbour). Pathways for regulatory acceptance of 3R testing approaches are depicted and a new procedure for submission and evaluation of a proposal for regulatory acceptance of 3R testing approaches is described.

"Unwalling" the Classroom: Teacher Reaction and Adaptation

ERIC Educational Resources Information Center

Deed, Craig; Lesko, Thomas

2015-01-01

Modern open school architecture abstractly expresses ideas about choice, flexibility and autonomy. While open spaces express and authorise different teaching practice, these versions of school and classrooms present challenges to teaching routines and practice. This paper examines how teachers adapt as they move into new school buildings designed…

A Generic Authentication LoA Derivation Model

NASA Astrophysics Data System (ADS)

Yao, Li; Zhang, Ning

One way of achieving a more fine-grained access control is to link an authentication level of assurance (LoA) derived from a requester’s authentication instance to the authorisation decision made to the requester. To realise this vision, there is a need for designing a LoA derivation model that supports the use and quantification of multiple LoA-effecting attributes, and analyse their composite effect on a given authentication instance. This paper reports the design of such a model, namely a generic LoA derivation model (GEA- LoADM). GEA-LoADM takes into account of multiple authentication attributes along with their relationships, abstracts the composite effect by the multiple attributes into a generic value, authentication LoA, and provides algorithms for the run-time derivation of LoA. The algorithms are tailored to reflect the relationships among the attributes involved in an authentication instance. The model has a number of valuable properties, including flexibility and extensibility; it can be applied to different application contexts and support easy addition of new attributes and removal of obsolete ones.

Technical Support Documents Used to Develop the Chesapeake Bay TMDL

EPA Pesticide Factsheets

The Chesapeake Bay TMDL development was supported by several technical documents for water quality standards and allocation methodologies specific to the Chesapeake Bay. This page provides the technical support documents.

SUPERFUND TECHNICAL SUPPORT

EPA Science Inventory

Under this task, technical support is provided to Regional Remedial Project Managers (RPMs)/On-Scene Coordinators (OSCs) at Superfund, RCRA, and Brownfields sites contaminated with hazardous materials by the Technical Support Center (TSC) for Monitoring and Site Characterization....

Providing Services to Virtual Patrons.

ERIC Educational Resources Information Center

Hulshof, Robert

1999-01-01

Discusses the types of services libraries need to support patrons who access the library via the Internet or e-mail. Highlights include issues in technical support; establishing policies and procedures; tools for technical support, including hardware and software; impacts of technical support on staff; and future possibilities. (LRW)

24 CFR 583.140 - Technical assistance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 3 2010-04-01 2010-04-01 false Technical assistance. 583.140... Technical assistance. (a) General. HUD may set aside funds annually to provide technical assistance, either... technical assistance is for the purpose of promoting the development of supportive housing and supportive...

Radiopharmaceuticals 1994. Nil desperandum. European Association of Nuclear Medicine Committees on Radiopharmaceuticals and Positron Emission Tomography.

PubMed

Cox, P H; Meyer, G J

1995-06-01

On the basis of the discussions at a symposium held in Düsseldorf and attended by representatives of various interested bodies, European legislation as it affects radiopharmaceuticals is reviewed. Due consideration is given to the new, centralised and decentralised, registration procedures, effective since 1 January 1995. The dossier required to support an application for marketing authorisation is discussed, separate consideration being given to single-photon emitters, therapeutic radio-nuclides and positron-emitting radiopharmaceuticals. The role of the European Pharmacopoiea is also considered. It is concluded that the new, modified procedures for the registration of medicinal products in the European Union may actually inhibit free availability of radio-pharmaceuticals within the Community, and that there is a strong case for modification of the European Directives so that radiopharmaceuticals are placed in a separate category to therapeutic drugs, with less stringent registration requirements.

Animal-Friendly Affinity Reagents: Replacing the Needless in the Haystack.

PubMed

Gray, A C; Sidhu, S S; Chandrasekera, P C; Hendriksen, C F M; Borrebaeck, C A K

2016-12-01

The multibillion-dollar global antibody industry produces an indispensable resource but that is generated using millions of animals. Despite the irrefutable maturation and availability of animal-friendly affinity reagents (AFAs) employing naïve B lymphocyte or synthetic recombinant technologies expressed by phage display, animal immunisation is still authorised for antibody production. Remarkably, replacement opportunities have been overlooked, despite the enormous potential reduction in animal use. Directive 2010/63/EU requires that animals are not used where alternatives exist. To ensure its implementation, we have engaged in discussions with the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) and the Directorate General for Environment to carve out an EU-led replacement strategy. Measures must be imposed to avoid outsourcing, regulate commercial production, and ensure that antibody producers are fully supported. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Technical Support for Contaminated Sites

EPA Science Inventory

In 1987, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD), Office of Land and Emergency Management, and EPA Regional waste management offices established the Technical Support Project. The creation of the Technical Support Project enabled...

Data governance in predictive toxicology: A review.

PubMed

Fu, Xin; Wojak, Anna; Neagu, Daniel; Ridley, Mick; Travis, Kim

2011-07-13

Due to recent advances in data storage and sharing for further data processing in predictive toxicology, there is an increasing need for flexible data representations, secure and consistent data curation and automated data quality checking. Toxicity prediction involves multidisciplinary data. There are hundreds of collections of chemical, biological and toxicological data that are widely dispersed, mostly in the open literature, professional research bodies and commercial companies. In order to better manage and make full use of such large amount of toxicity data, there is a trend to develop functionalities aiming towards data governance in predictive toxicology to formalise a set of processes to guarantee high data quality and better data management. In this paper, data quality mainly refers in a data storage sense (e.g. accuracy, completeness and integrity) and not in a toxicological sense (e.g. the quality of experimental results). This paper reviews seven widely used predictive toxicology data sources and applications, with a particular focus on their data governance aspects, including: data accuracy, data completeness, data integrity, metadata and its management, data availability and data authorisation. This review reveals the current problems (e.g. lack of systematic and standard measures of data quality) and desirable needs (e.g. better management and further use of captured metadata and the development of flexible multi-level user access authorisation schemas) of predictive toxicology data sources development. The analytical results will help to address a significant gap in toxicology data quality assessment and lead to the development of novel frameworks for predictive toxicology data and model governance. While the discussed public data sources are well developed, there nevertheless remain some gaps in the development of a data governance framework to support predictive toxicology. In this paper, data governance is identified as the new challenge in predictive toxicology, and a good use of it may provide a promising framework for developing high quality and easy accessible toxicity data repositories. This paper also identifies important research directions that require further investigation in this area.

Data governance in predictive toxicology: A review

PubMed Central

2011-01-01

Background Due to recent advances in data storage and sharing for further data processing in predictive toxicology, there is an increasing need for flexible data representations, secure and consistent data curation and automated data quality checking. Toxicity prediction involves multidisciplinary data. There are hundreds of collections of chemical, biological and toxicological data that are widely dispersed, mostly in the open literature, professional research bodies and commercial companies. In order to better manage and make full use of such large amount of toxicity data, there is a trend to develop functionalities aiming towards data governance in predictive toxicology to formalise a set of processes to guarantee high data quality and better data management. In this paper, data quality mainly refers in a data storage sense (e.g. accuracy, completeness and integrity) and not in a toxicological sense (e.g. the quality of experimental results). Results This paper reviews seven widely used predictive toxicology data sources and applications, with a particular focus on their data governance aspects, including: data accuracy, data completeness, data integrity, metadata and its management, data availability and data authorisation. This review reveals the current problems (e.g. lack of systematic and standard measures of data quality) and desirable needs (e.g. better management and further use of captured metadata and the development of flexible multi-level user access authorisation schemas) of predictive toxicology data sources development. The analytical results will help to address a significant gap in toxicology data quality assessment and lead to the development of novel frameworks for predictive toxicology data and model governance. Conclusions While the discussed public data sources are well developed, there nevertheless remain some gaps in the development of a data governance framework to support predictive toxicology. In this paper, data governance is identified as the new challenge in predictive toxicology, and a good use of it may provide a promising framework for developing high quality and easy accessible toxicity data repositories. This paper also identifies important research directions that require further investigation in this area. PMID:21752279

A statistical approach to quantification of genetically modified organisms (GMO) using frequency distributions.

PubMed

Gerdes, Lars; Busch, Ulrich; Pecoraro, Sven

2014-12-14

According to Regulation (EU) No 619/2011, trace amounts of non-authorised genetically modified organisms (GMO) in feed are tolerated within the EU if certain prerequisites are met. Tolerable traces must not exceed the so-called 'minimum required performance limit' (MRPL), which was defined according to the mentioned regulation to correspond to 0.1% mass fraction per ingredient. Therefore, not yet authorised GMO (and some GMO whose approvals have expired) have to be quantified at very low level following the qualitative detection in genomic DNA extracted from feed samples. As the results of quantitative analysis can imply severe legal and financial consequences for producers or distributors of feed, the quantification results need to be utterly reliable. We developed a statistical approach to investigate the experimental measurement variability within one 96-well PCR plate. This approach visualises the frequency distribution as zygosity-corrected relative content of genetically modified material resulting from different combinations of transgene and reference gene Cq values. One application of it is the simulation of the consequences of varying parameters on measurement results. Parameters could be for example replicate numbers or baseline and threshold settings, measurement results could be for example median (class) and relative standard deviation (RSD). All calculations can be done using the built-in functions of Excel without any need for programming. The developed Excel spreadsheets are available (see section 'Availability of supporting data' for details). In most cases, the combination of four PCR replicates for each of the two DNA isolations already resulted in a relative standard deviation of 15% or less. The aims of the study are scientifically based suggestions for minimisation of uncertainty of measurement especially in -but not limited to- the field of GMO quantification at low concentration levels. Four PCR replicates for each of the two DNA isolations seem to be a reasonable minimum number to narrow down the possible spread of results.

EPA'S GROUND WATER TECHNICAL SUPPORT CENTER

EPA Science Inventory

The purpose and the services provided by EPA's Ground Water Technical Support Center (GWTSC) will be presented. In 1987 the Office of Solid Waste and Emergency Response, Regional Waste Management Offices, and ORD established the Technical Support Project (TSP)

The purpos...

7 CFR 652.35 - State Conservationist decision.

Code of Federal Regulations, 2010 CFR

2010-01-01

... technical service provider, the technical service provider will be given written notice of that... technical service provider's written response and supporting documentation. Both a copy of the decision and..., DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE Decertification § 652.35...

My "Ill" Literacy Narrative: Growing up Black, Po and a Girl, in the Hood

ERIC Educational Resources Information Center

Richardson, Elaine

2009-01-01

Hegemonic discourses authorise certain ways of being, knowing, and doing. We internalise or appropriate images, patterns, and words from the social activities in which we have participated. Race, gender, sexuality, age, education, class are among aspects of identity (social constructions) that affect our language and literacy acquisition, the way…

Becoming an "Authorised" Postgraduate Research Writer

ERIC Educational Resources Information Center

James, Bronwyn

2012-01-01

Within the context of postgraduate research education and training in the higher education sector, drafting might be understood as "not quite the final product" produced by the student who is "not yet the final product" of the university. In this paper, I turn this assumption "off centre" to argue instead that writing and subjectivity are mutually…

Lubiprostone for chronic constipation in adults.

PubMed

2014-04-01

Lubiprostone (Amitiza-Sucampo Pharma Europe), a chloride-channel activator is licensed for the treatment of chronic idiopathic constipation in adults. It received a marketing authorisation in the UK in September 2012. In this article, we consider the evidence for lubiprostone in the management of constipation and how the treatment fits with current management strategies for constipation.

[Regulatory control of new medicines: help or hindrance?].

PubMed

Vozeh, S

1999-04-15

To answer the question of the benefit and the cost/benefit ratio of the activities of a drug regulatory agency, the most important, clinically relevant "products" of a licensing authority in general, and the Swiss licensing authority (IKS) in particular are discussed. The activities of the medicines licensing authority assure that: For all new substances the efficacy and a positive benefit/risk ratio have been demonstrated before a marketing authorisation. For all marketed medicines an information for professionals and patients is available that has been evaluated and approved by an independent and competent reviewer. An independent post marketing surveillance of the side effects profile continues after a medicine has been put on the market. All clinical trials investigating medicinal products are performed according to GCP rules corresponding to international ethical and scientific standards. An international comparison of the time needed for the evaluation of a marketing authorisation application for a new medicine reveals that the IKS is one of the most efficient agencies. This is illustrated with an example showing the evaluation times of the EMEA and the IKS for products approved in 1997.

A practical approach to screen for authorised and unauthorised genetically modified plants.

PubMed

Waiblinger, Hans-Ulrich; Grohmann, Lutz; Mankertz, Joachim; Engelbert, Dirk; Pietsch, Klaus

2010-03-01

In routine analysis, screening methods based on real-time PCR are most commonly used for the detection of genetically modified (GM) plant material in food and feed. In this paper, it is shown that the combination of five DNA target sequences can be used as a universal screening approach for at least 81 GM plant events authorised or unauthorised for placing on the market and described in publicly available databases. Except for maize event LY038, soybean events DP-305423 and BPS-CV127-9 and cotton event 281-24-236 x 3006-210-23, at least one of the five genetic elements has been inserted in these GM plants and is targeted by this screening approach. For the detection of these sequences, fully validated real-time PCR methods have been selected. A screening table is presented that describes the presence or absence of the target sequences for most of the listed GM plants. These data have been verified either theoretically according to available databases or experimentally using available reference materials. The screening table will be updated regularly by a network of German enforcement laboratories.

Nurses and electronic health records in a Canadian hospital: examining the social organisation and programmed use of digitised nursing knowledge.

PubMed

Campbell, Marie L; Rankin, Janet M

2017-03-01

Institutional ethnography (IE) is used to examine transformations in a professional nurse's work associated with her engagement with a hospital's electronic health record (EHR) which is being updated to integrate professional caregiving and produce more efficient and effective health care. We review in the technical and scholarly literature the practices and promises of information technology and, especially of its applications in health care, finding useful the more critical and analytic perspectives. Among the latter, scholarship on the activities of economising is important to our inquiry into the actual activities that transform 'things' (in our case, nursing knowledge and action) into calculable information for objective and financially relevant decision-making. Beginning with an excerpt of observational data, we explicate observed nurse-patient interactions, discovering in them traces of institutional ruling relations that the nurse's activation of the EHR carries into the nursing setting. The EHR, we argue, materialises and generalises the ruling relations across institutionally located caregivers; its authorised information stabilises their knowing and acting, shaping health care towards a calculated effective and efficient form. Participating in the EHR's ruling practices, nurses adopt its ruling standpoint; a transformation that we conclude needs more careful analysis and debate. © 2016 Foundation for the Sociology of Health & Illness.

Technical Support Document for Version 3.6.1 of the COMcheck Software

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bartlett, Rosemarie; Connell, Linda M.; Gowri, Krishnan

2009-09-29

This technical support document (TSD) is designed to explain the technical basis for the COMcheck software as originally developed based on the ANSI/ASHRAE/IES Standard 90.1-1989 (Standard 90.1-1989). Documentation for other national model codes and standards and specific state energy codes supported in COMcheck has been added to this report as appendices. These appendices are intended to provide technical documentation for features specific to the supported codes and for any changes made for state-specific codes that differ from the standard features that support compliance with the national model codes and standards.

Ground Water Technical Support Center (GWTSC) Annual ...

EPA Pesticide Factsheets

The Ground Water Technical Support Center (GWTSC) is part of the Ground Water and Ecosystems Restoration Division (GWERD), which is based in the Robert S. Kerr Environmental Research Center in Ada, Oklahoma. The GWERD is a research division of U.S. EPA’s National Risk Management Research Laboratory (NRMRL). The GWTSC is one of an interlinked group of specialized Technical Support Centersthat were established under the Technical Support Project (TSP). The GWTSC provides technical support on issues related to groundwater. Specifically, the GWTSC provides technical support to U.S. EPA and State regulators for issues and problems related to:1. subsurface contamination (contaminants in ground water, soils and sediments),2. cross-media transfer (movement of contaminants from the subsurface to other media such as surface water or air), and3. restoration of impacted ecosystems.The GWTSC works with Remedial Project Managers (RPMs) and other decision makers to solve specific problems at Superfund, RCRA (Resource Conservation and Recovery Act), Brownfields sites, and ecosystem restoration sites. The Ground Water Technical Support Center (GWTSC) is part of the Ground Water and Ecosystems Restoration Division (GWERD), which is based in the Robert S. Kerr Environmental Research Center in Ada, Oklahoma. The GWERD is a research division of U.S. EPA’s National Risk Management Research Laboratory (NRMRL). The GWTSC is one of an interlinked group of specialized Technical Suppo

Preparation of medicines for children - a hierarchy of classification.

PubMed

Ernest, Terry B; Craig, Jo; Nunn, Anthony; Salunke, Smita; Tuleu, Catherine; Breitkreutz, Joerg; Alex, Rainer; Hempenstall, John

2012-10-05

There is some confusion about the types of paediatric pharmaceutical preparation (in a regulatory and pharmaceutical development context) that are acceptable for approval by medicines regulators. Some of the confusion relates to terminology which may mean different things to different stakeholders. It may not always be possible to provide authorised, commercially manufactured, age appropriate, ready-to-administer preparations. In terms of assurance of quality and bioavailability there is a continuum from this ideal through intermediate products through authorised compounding and manipulation of commercial dosage forms to ad hoc compounding using only the skills and experience of the individual pharmacist. Additionally, it is widely known that caregivers may manipulate medicines at home, for example by segmenting tablets and by addition to foods or liquids. The first intent of the manufacturer should be to provide for children an age appropriate, ready-to-administer preparation which is commercially manufactured and approved by the competent authorities. However, there will still be a place for providing other age appropriate preparations such as approved products that are 'intermediates' requiring reconstitution before use, or instructions for compounding or manipulation of a dosage form. If compounding or manipulation is likely to be required it is preferable that data are generated by Industry, approved by the competent authorities and provided in the Summary of Product Characteristics (SmPC). It is acknowledged however, that ad hoc compounding or manipulation may also take place in certain circumstances such as logistical difficulties or to satisfy the needs of the child who does not find the authorised product to be 'age appropriate'. This paper explores compounding and manipulation of medicines in relation to approval by medicines regulators and non-approved preparation to fulfil the needs of the individual patient. Definitions are proposed to provide a hierarchical classification based on assurances of quality and bioavailability. Copyright © 2012 Elsevier B.V. All rights reserved.

Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study.

PubMed

Lexchin, Joel

2018-04-28

This study examines the characteristics of studies that Health Canada uses to grant full marketing authorisation for products given a conditional approval between 1 January 1998 and 30 June 2017. Cohort study. Journal articles listing drugs that fulfilled their conditions and received full marketing authorisation, Notice of Compliance database, Notice of Compliance with conditions website, Qualifying Notices listing required confirmatory studies, clinicaltrials.gov, PubMed, Embase, companies making products being analysed, journal articles resulting from confirmatory studies. None. Characteristics of studies-study design (randomised controlled trials, observational), primary outcome used (clinical, surrogate), blinding, number of patients in studies, patient median age, number of men and women. Eleven companies confirmed 36 publications for 19 products (21 indications). Twenty-nine out of the 36 studies were randomised controlled trials (RCTs) but only 10 stated if they were blinded. Twenty used surrogate outcomes. The median age of patients was 56 (IQR 44-61). The median number of men per study/trial was 184 (IQR 58-514) versus women 141 (IQR 46-263). Postmarket studies required by Health Canada had more rigorous methodology than those required by either the Food and Drug Administration or the European Medicines Agency. There were still deficiencies in these studies. The absence of blinding in the majority of RCTs may introduce bias in their results. The use of surrogate outcomes especially in oncology trials means that improvements in survival are not available. The relatively young age of patients, even for products for cancer, means that predicting how the elderly will respond is often unknown. The almost universal finding that men outnumbered women may make it hard to differentiate responses by sex. These results raise potential concerns about the quality of evidence that Health Canada accepts. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Internet-using men who have sex with men would be interested in accessing authorised HIV self-tests available for purchase online.

PubMed

Greacen, Tim; Friboulet, David; Blachier, Audrey; Fugon, Lionel; Hefez, Serge; Lorente, Nicolas; Spire, Bruno

2013-01-01

Men who have sex with men (MSM) recruited in sex venues have been shown to be interested in accessing HIV home-tests if reliable and authorised tests were available. To what extent is this true for MSM recruited online? In an online survey in French on the use of unauthorised HIV home-tests purchased online, MSM previously unaware of the existence of these tests were asked if they would be interested in accessing them if these tests were authorised. Among 5908 non-HIV positive respondents, 86.5% expressed interest. Independent variables associated with interest included: being younger, living in smaller towns, having a job but not tertiary education and living in a conventional family with one's parents or a wife and family. Interested men were also more likely to have never done the standard HIV test or not in the last year, to have casual sex partners but on average not more than once a week, to take sexual risks with these partners, to live their sex-lives with men in absolute secrecy and yet often to try to make a date to see their sex partners again. Of the 5109 respondents interested in accessing self-tests purchasable online, 4362 (85.4%) answered an open question on their reasons for being interested. Using thematic analysis, principle themes identified proved to be similar to those found in earlier studies with MSM recruited in sex venues: convenience, rapidity accessing results and privacy. In answer to a closed question, men not interested chose as reasons: satisfaction with current method, doubts about reliability, not wanting to be alone when discovering results and fear of incorrect use. In conclusion, although the online questionnaire may have introduced selection bias over-representing men already interested, many Internet-using MSM are interested in accessing self-tests available for purchase online.

Study protocol for a transversal study to develop a screening model for excessive gambling behaviours on a representative sample of users of French authorised gambling websites

PubMed Central

Hardouin, Jean-Benoit; Grall-Bronnec, Marie; Challet-Bouju, Gaëlle

2017-01-01

Introduction Since the legalisation of online gambling in France in 2010, gambling operators must implement responsible gambling measures to prevent excessive gambling practices. However, actually there is no screening procedure for identifying problematic gamblers. Although several studies have already been performed using several data sets from online gambling operators, the authors deplored several methodological and clinical limits that prevent scientifically validating the existence of problematic gambling behaviour. The aim of this study is to develop a model for screening excessive gambling practices based on the gambling behaviours observed on French gambling websites, coupled with a clinical validation. Methods and analysis The research is divided into three successive stages. All analyses will be performed for each major type of authorised online gambling in France. The first stage aims at defining a typology of users of French authorised gambling websites based on their gambling behaviour. This analysis will be based on data from the Authority for Regulating Online Gambling (ARJEL) and the Française Des Jeux (FDJ). For the second stage aiming at determining a score to predict whether a gambler is problematic or not, we will cross answers from the Canadian Problem Gambling Index with real gambling data. The objective of the third stage is to clinically validate the score previously developed. Results from the screening model will be compared (using sensitivity, specificity, area under the curve, and positive and negative predictive values) with the diagnosis obtained with a telephone clinical interview, including diagnostic criteria for gambling addiction. Ethics and dissemination This study was approved by the local Research Ethics Committee (GNEDS) on 25 March 2015. Results will be presented in national and international conferences, submitted to peer-reviewed journals and will be part of a PhD thesis. A final report with the study results will be presented to the ARJEL, especially the final screening model. Trial registration number NCT02415296. PMID:28515192

Analysis of stakeholders networks of infant and young child nutrition programmes in Sri Lanka, India, Nepal, Bangladesh and Pakistan.

PubMed

Uddin, Shahadat; Mahmood, Hana; Senarath, Upul; Zahiruddin, Quazi; Karn, Sumit; Rasheed, Sabrina; Dibley, Michael

2017-06-13

Effective public policies are needed to support appropriate infant and young child feeding (IYCF) to ensure adequate child growth and development, especially in low and middle income countries. The aim of this study was to: (i) capture stakeholder networks in relation to funding and technical support for IYCF policy across five countries in South Asia (i.e. Sri Lanka, India, Nepal, Bangladesh and Pakistan); and (ii) understand how stakeholder networks differed between countries, and identify common actors and their patterns in network engagement across the region. The Net-Map method, which is an interview-based mapping technique to visualise and capture connections among different stakeholders that collaborate towards achieving a focused goal, has been used to map funding and technical support networks in all study sites. Our study was conducted at the national level in Bangladesh, India, Nepal, and Sri Lanka, as well as in selected states or provinces in India and Pakistan during 2013-2014. We analysed the network data using a social network analysis software (NodeXL). The number of stakeholders identified as providing technical support was higher than the number of stakeholders providing funding support, across all study sites. India (New Delhi site - national level) site had the highest number of influential stakeholders for both funding (43) and technical support (86) activities. Among all nine study sites, India (New Delhi - national level) and Sri Lanka had the highest number of participating government stakeholders (22) in their respective funding networks. Sri Lanka also had the highest number of participating government stakeholders for technical support (34) among all the study sites. Government stakeholders are more engaged in technical support activities compared with their involvement in funding activities. The United Nations Children's Emergency Fund (UNICEF) and the World Health Organization (WHO) were highly engaged stakeholders for both funding and technical support activities across all study sites. International stakeholders were highly involved in both the funding and technical support activities related to IYCF practices across these nine study sites. Government stakeholders received more support for funding and technical support activities from other stakeholders compared with the support that they offered. Stakeholders were, in general, more engaged for technical support activities compared with the funding activities.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

PubMed

Kroes, Burt H

2014-12-02

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products. Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Identifying Effective Strategies to Providing Technical Support to One-to-One Programs

ERIC Educational Resources Information Center

Thomas, Mark W.

2013-01-01

The problem of this study was that while one-to-one initiatives in the K-12 environment are growing, the technical support personnel that work in these environments are experiencing problems supporting these initiatives. The purposes of this study were to: (a) identify common problems of providing technical support in a one-to-one laptop program,…

75 FR 19297 - Energy Conservation Program: Public Meeting and Availability of the Preliminary Technical Support...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-14

... Conservation Program: Public Meeting and Availability of the Preliminary Technical Support Document for Walk-In... and availability of the preliminary technical support document regarding energy conservation standards..., the deadline for requesting to speak at the public meeting, and the deadline for submitting written...

40 CFR Appendix A to Part 67 - Technical Support Document

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Technical Support Document A Appendix A to Part 67 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...—Technical Support Document Note: EPA will make copies of appendix A available from: Director, Stationary...

40 CFR Appendix A to Part 66 - Technical Support Document

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Technical Support Document A Appendix A to Part 66 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...—Technical Support Document Note: For text of appendix A see appendix A to part 67. ...

Degrees of Doubt? Towards Eradicating Fraudulent Cross-Border Institutions and Diplomas

ERIC Educational Resources Information Center

Observatory on Borderless Higher Education, 2010

2010-01-01

Six higher education institutions in Singapore and four universities in New Zealand have reportedly been placed on a list of unaccredited institutions and so-called "degree mills", which has been compiled by the Office of Degree Authorisation of the state of Oregon in the United States (US). As one of the first US states that introduced…

Threat Modelling Adobe PDF

DTIC Science & Technology

2012-08-01

this attack sensitive information relating to their two-factor authentication process, employed within RSA’s products, was stolen; potentially... authenticated session the victim has with another website. This could allow the attacker to impersonate the victim or obtain sensitive information...all that is not blacklisted is authorised . We will outline relevant security settings in this section. 4.1 Adobe End-User Security Modification

Using State-Wide Multiple Measures for School Leadership and Management: Costs Incurred vs. Benefits Gained

ERIC Educational Resources Information Center

Hentschke, Guilbert; Wohlstetter, Priscilla; Hirman, Jennifer; Zeehandelaar, Dara

2011-01-01

In this article, we examine the utility and value of multiple measures of school performance for school leaders and managers. The research was conducted within the context of the state of California through an investigation of how operators, managers and authorisers of autonomous "charter" (publicly financed but privately operated)…

40 CFR 412.31 - Effluent limitations attainable by the application of the best practicable control technology...

Code of Federal Regulations, 2010 CFR

2010-07-01

... supporting technical analysis and any other relevant information and data that would support such site... event. The technical analysis of the discharge of pollutants must include: (A) All daily inputs to the... the supporting technical analysis, including inspection of the CAFO. (3) The CAFO shall attain the...

40 CFR 412.31 - Effluent limitations attainable by the application of the best practicable control technology...

Code of Federal Regulations, 2011 CFR

2011-07-01

... supporting technical analysis and any other relevant information and data that would support such site... event. The technical analysis of the discharge of pollutants must include: (A) All daily inputs to the... the supporting technical analysis, including inspection of the CAFO. (3) The CAFO shall attain the...

Engineering Technical Support Center Annual Report Fiscal ...

EPA Pesticide Factsheets

The United States Environmental Protection Agency (EPA or Agency) Office of Research and Development (ORD) created the Engineering Technical Support Center (ETSC) in 1987, one of several technical support centers created as part of the Technical Support Project (TSP). ETSC provides engineering expertise to Agency program and regional offices and remediation teams working at contaminated sites across the country. The ETSC is operated within ORD’s Land Remediation and Pollution Control Division (LRPCD) of the National Risk Management Research Laboratory (NRMRL) in Cincinnati, Ohio. The ETSC’s mission is to provide site-specific scientific and engineering technical support to Remedial Project Managers, On-Scene Coordinators, and other remediation personnel at contaminated sites. This allows local, regional, or national authorities to work more quickly, efficiently, and cost effectively, while also increasing the technical experience of the remediation team. Since its inception, the ETSC has supported countless projects across all EPA Regions in almost all states and territories. This report highlights significant projects the ETSC supported in fiscal year 2015 (FY15). These projects addressed an array of environmental scenarios, such as remote mining contamination, expansive landfill waste, cumulative impacts from multiple contamination sources, and persistent threats from abandoned industrial sites. Constructing and testing new and innovative treatment technol

The CHPRC Groundwater and Technical Integration Support (Master Project) Quality Assurance Management Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fix, N. J.

The scope of the CH2M Hill Plateau Remediation Company, LLC (CHPRC) Groundwater and Technical Integration Support (Master Project) is for Pacific Northwest National Laboratory staff to provide technical and integration support to CHPRC. This work includes conducting investigations at the 300-FF-5 Operable Unit and other groundwater operable units, and providing strategic integration, technical integration and assessments, remediation decision support, and science and technology. The projects under this Master Project will be defined and included within the Master Project throughout the fiscal year, and will be incorporated into the Master Project Plan. This Quality Assurance Management Plan provides the quality assurancemore » requirements and processes that will be followed by the CHPRC Groundwater and Technical Integration Support (Master Project) and all releases associated with the CHPRC Soil and Groundwater Remediation Project. The plan is designed to be used exclusively by project staff.« less

Engineering Technical Support Center (ETSC)

EPA Pesticide Factsheets

ETSC is EPA’s technical support and resource centers responsible for providing specialized scientific and engineering support to decision-makers in the Agency’s ten regional offices, states, communities, and local businesses.

"Good Girls": Emphasised Femininity as Cloning Culture in Academia

ERIC Educational Resources Information Center

Mattsson, Tina

2015-01-01

Gender inequality in academia might be understood as an effect of the belief of a contradiction between woman and science, which make it difficult for women to appropriate the right to author and authorise acts of knowing and thinking in science. In relation to this concern, the aim of this article is to explore how a group of successful women…

Investigating "Race" and Social Cohesion at the University of KwaZulu-Natal

ERIC Educational Resources Information Center

Pattman, R.

2010-01-01

In the light of the notorious video made by white students at the University of Free State (UFS) in which black middle aged cleaners were subjected to forms of degradation in a mock initiation ceremony (which included being given food mixed with urine) the Minister of Education authorised an investigation on social cohesion in universities. The…

Interrogating the Nature of the "Universal" in South Africa's New Educational Order

ERIC Educational Resources Information Center

Soudien, Crain

2011-01-01

This paper examines the relationship between the South African knowledge enterprise and citizenship in terms of the ontologies it authorises. It is especially interested in how education comes to be used in particular settings to privilege particular ways of being. In relation to this it asks what notions of the subject and his or her relation to…

U.S. ENVIRONMENTAL PROTECTION AGENCY RESEARCH AND TECHNICAL SUPPORT NEEDS RELATED TO CONCEPTUAL MODEL DEVELOPMENT FOR SUBSURFACE REACTIVE TRANSPORT MODELING OF INORGANIC CONTAMINANTS, RADIONUCLIDES, AND NUTRIENTS

EPA Science Inventory

EPA's Office of Research and Development is responsible to EPA's Office of Solid Waste to provide research and technical support for waste site closures and the development of technical guidance in support of environmental regulations and programmatic policies. ORD is also respo...

Improving drug policy: The potential of broader democratic participation.

PubMed

Ritter, Alison; Lancaster, Kari; Diprose, Rosalyn

2018-05-01

Policies concerned with illicit drugs vex governments. While the 'evidence-based policy' paradigm argues that governments should be informed by 'what works', in practice policy makers rarely operate this way. Moreover the evidence-based policy paradigm fails to account for democratic participatory processes, particularly how community members and people who use drugs might be included. The aim of this paper is to explore the political science thinking about democratic participation and the potential afforded in 'deliberative democracy' approaches, such as Citizens Juries and other mini-publics for improved drug policy processes. Deliberative democracy, through its focus on inclusion, equality and reasoned discussion, shows potential for drug policy reform and shifts the focus from reliance on and privileging of experts and scientific evidence. But the very nature of this kind of 'deliberation' may delimit participation, notably through its insistence on authorised modes of communication. Other forms of participation beyond reasoned deliberation aligned with the ontological view that participatory processes themselves are constitutive of subject positions and policy problems, may generate opportunities for considering how the deleterious effects of authorised modes of communication might be overcome. Copyright © 2018 Elsevier B.V. All rights reserved.

Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

PubMed

Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

2010-01-01

The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

Development of real-time PCR tests for the detection of Tenebrio molitor in food and feed.

PubMed

Debode, Frédéric; Marien, Aline; Gérard, Amaury; Francis, Frédéric; Fumière, Olivier; Berben, Gilbert

2017-08-01

Insects are rich in proteins and could be an alternative source of proteins to feed animals and humans. Numerous companies have started the production of insects for feed purposes. In Europe, these processed animal proteins are not yet authorised by legislation as many questions still need to be answered concerning this 'novel food'. Authorisations will be possible when methods of authentication of the products are available. In this study we propose real-time PCR methods for the specific detection of the mealworm (Tenebriomolitor), one of the most widely used insects for food and feed production. Two PCR assays are proposed: the first based on the wingless gene and the second based on the cadherin gene. The PCR tests amplify fragments of 87 bp. These qualitative methods were tested according to several performance criteria. The specificity was tested on 34 insect species' DNA, but also on non-insect species including crustacean, mammals, birds and plants. The limit of detection was determined and was below 20 copies for the two PCR tests. The applicability of the tests was demonstrated by the analysis of real-life processed samples containing T. molitor.

Moving Controlled Vocabularies into the Semantic Web

NASA Astrophysics Data System (ADS)

Thomas, R.; Lowry, R. K.; Kokkinaki, A.

2015-12-01

One of the issues with legacy oceanographic data formats is that the only tool available for describing what a measurement is and how it was made is a single metadata tag known as the parameter code. The British Oceanographic Data Centre (BODC) has been supporting the international oceanographic community gain maximum benefit from this through a controlled vocabulary known as the BODC Parameter Usage Vocabulary (PUV). Over time this has grown to over 34,000 entries some of which have preferred labels with over 400 bytes of descriptive information detailing what was measured and how. A decade ago the BODC pioneered making this information available in a more useful form with the implementation of a prototype vocabulary server (NVS) that referenced each 'parameter code' as a URL. This developed into the current server (NVS V2) in which the parameter URL resolves into an RDF document based on the SKOS data model which includes a list of resource URLs mapped to the 'parameter'. For example the parameter code for a contaminant in biota, such as 'cadmium in Mytilus edulis', carries RDF triples leading to the entry for Mytilus edulis in the WoRMS and for cadmium in the ChEBI ontologies. By providing links into these external ontologies the information captured in a 1980s parameter code now conforms to the Linked Data paradigm of the Semantic Web, vastly increasing the descriptive information accessible to a user. This presentation will describe the next steps along the road to the Semantic Web with the development of a SPARQL end point1 to expose the PUV plus the 190 other controlled vocabularies held in NVS. Whilst this is ideal for those fluent in SPARQL, most users require something a little more user-friendly and so the NVS browser2 was developed over the end point to allow less technical users to query the vocabularies and navigate the NVS ontology. This tool integrates into an editor that allows vocabulary content to be manipulated by authorised users outside BODC. Having placed Linked Data tooling over a single SPARQL end point the obvious future development for this system is to support semantic interoperability outside NVS by the incorporation of federated SPARQL end points in the USA and Australia during the ODIP II project. 1https://vocab.nerc.ac.uk/sparql 2 https://www.bodc.ac.uk/data/codes_and_formats/vocabulary_search/

Technical Assistance and Program Support; DOD Historical Black Colleges and Universities and Minority Institutions Program.

DTIC Science & Technology

2000-04-01

AD Award Number: DAMD17-98-2-8012 TITLE: Technical Assistance and Program Support; DOD Historical Black Colleges and Universities and Minority...2000 3. REPORT TYPE AND DATES COVERED Annual (1 May 99 - 30 Apr 00): 4. TITLE AND SUBTITLE Technical Assistance and Program Support; DOD...UNCF’s Infrastructure Development Assistance Program (IDAP) has been involved myriad of tasks to support the Department of Defense’s interest to

77 FR 40026 - 36(b)(1) Arms Sales Notification

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... and contractor logistics, Quality Assurance Team support services, engineering and technical support..., engineering and technical support, and other related elements of program support. The estimated cost is $49..., maintenance, or training is Confidential. Reverse engineering could reveal Confidential information...

48 CFR 2052.215-75 - Proposal presentation and format.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., i.e., competitive vs. noncompetitive, and the cost evaluation. (c) “Written Technical and Management... * copies. (1) The written Technical and Management Proposal or Oral Presentation and Supporting... objectives of this procurement. (3) The written Technical Proposal or Oral Presentation and Supporting...

The power of a collaborative relationship between technical assistance providers and community prevention teams: A correlational and longitudinal study

PubMed Central

Chilenski, Sarah M.; Perkins, Daniel F.; Olson, Jonathan; Hoffman, Lesa; Feinberg, Mark E.; Greenberg, Mark; Welsh, Janet; Crowley, D. Max; Spoth, Richard

2015-01-01

Background Historically, effectiveness of community collaborative prevention efforts has been mixed. Consequently, research has been undertaken to better understand the factors that support their effectiveness; theory and some related empirical research suggests that the provision of technical assistance is one important supporting factor. The current study examines one aspect of technical assistance that may be important in supporting coalition effectiveness, the collaborative relationship between the technical assistance provider and site lead implementer. Methods Four and one-half years of data were collected from technical assistance providers and prevention team members from the 14 community prevention teams involved in the PROSPER project. Results Spearman correlation analyses with longitudinal data show that the levels of the collaborative relationship during one phase of collaborative team functioning associated with characteristics of internal team functioning in future phases. Conclusions Results suggest that community collaborative prevention work should consider the collaborative nature of the technical assistance provider – prevention community team relationship when designing and conducting technical assistance activities, and it may be important to continually assess these dynamics to support high quality implementation. PMID:26476860

May we practise endotracheal intubation on the newly dead?

PubMed Central

Ardagh, M

1997-01-01

Endotracheal intubation (ETI) is a valuable procedure which must be learnt and practised, and performing ETI on cadavers is probably the best way to do this, although lesser alternatives do exist. Performing ETI on a cadaver is viewed with a real and reasonable repugnance and if it is done without proper authorisation it might be illegal. Some form of consent is required. Presumed consent would preferably be governed by statute and should only occur if the community is well informed and therefore in a position of being able to decline. Currently neither statute nor adequate informing exists. Endotracheal intubation on the newly dead may be justifiable according to a Guttman scale if the patient has already consented to organ donation and if further research supports the relevance of the Guttman scale to this question. A "mandated choice" with prior individual consent as a matter of public policy is the best of these solutions, however until such a solution is in place we may not practise endotracheal intubation on the newly dead. PMID:9358348

Judicial oversight of life-ending withdrawal of assisted nutrition and hydration in disorders of consciousness in the United Kingdom: A matter of life and death

PubMed Central

Rady, Mohamed Y; Verheijde, Joseph L.

2017-01-01

Mr Justice Baker delivered the Oxford Shrieval Lecture ‘A Matter of Life and Death’ on 11 October 2016. The lecture created public controversies about who can authorise withdrawal of assisted nutrition and hydration (ANH) in disorders of consciousness (DOC). The law requires court permission in ‘best interests’ decisions before ANH withdrawal only in permanent vegetative state and minimally conscious state. Some clinicians favour abandoning the need for court approval on the basis that clinicians are already empowered to withdraw ANH in other common conditions of DOC (e.g. coma, neurological disorders, etc.) based on their best interests assessment without court oversight. We set out a rationale in support of court oversight of best interests decisions in ANH withdrawal intended to end life in any person with DOC (who will lack relevant decision-making capacity). This ensures the safety of the general public and the protection of vulnerable disabled persons in society. PMID:28368210

The Eluana Englaro Case: cause of death after the withdrawal of artificial nutrition and hydration in a subject in a permanent vegetative state and with quadriplegia.

PubMed

Moreschi, Carlo; Da Broi, Ugo; Rodriguez, Daniele; Froldi, Rino; Porzionato, Andrea; Macchi, Veronica; De Caro, Raffaele

2013-09-10

A 38-year-old woman, who had been in a permanent vegetative state with quadriplegia for 17 years following a motor vehicle accident, died 87 h after the judicially authorised suspension of artificial nutrition and hydration. Medico-legal investigations, requested by the Judicial Authorities and focusing on the evaluation of clinical and necroscopic data, aimed to explain the cause of death, to exclude any lethal cause other than one deriving from the withdrawal of artificial nutrition and hydration and to verify the level of perceived discomfort and the correctness in the application of the supportive protocol during the end of life phase. The inability of quadriplegic patients to compensate critical hyperthermic and haemodynamic disturbances induced by dehydration was considered to be the cause of a rapid demise after the withdrawal of artificial sustenance. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Spatial Data Uncertainty in a Webgis Tool Supporting Sediments Management in Wallonia

NASA Astrophysics Data System (ADS)

Stéphenne, N. R.; Beaumont, B.; Veschkens, M.; Palm, S.; Charlemagne, C.

2015-08-01

This paper describes a WebGIS prototype developed for the Walloon administration to improve the communication and the management of sediments dredging actions carried out in rivers and lakes. In Wallonia, levelling dredged sediments on banks requires an official authorization from the administration. This request refers to geospatial datasets such as the official land use map, the cadastral map or the distance to potential pollution sources. Centralising geodatabases within a web interface facilitate the management of these authorizations for the managers and the central administration. The proposed system integrates various data from disparate sources. Some issues in map scale, spatial search quality and cartographic visualisation are discussed in this paper with the solutions provided. The prototype web application is currently discussed with some potential users in order to understand in which way this tool facilitate the communication, the management and the quality of the authorisation process. The structure of the paper states the why, what, who and how of this communication tool with a special focus on errors and uncertainties.

2005 v4.2 Technical Support Document

EPA Pesticide Factsheets

Technical Support Document for the Final Transport Rule describes how updated 2005 NEI, version 2 emissions and were processed for air quality modeling in support of the Cross-state Air Pollution Rule (CSAPR).

Organizational Structures and Processes to Support and Sustain Effective Technical Assistance in a State-Wide Multi-Tiered System of Support Initiative

ERIC Educational Resources Information Center

Morrison, Julie Q.; Russell, Christine; Dyer, Stephanie; Metcalf, Terri; Rahschulte, Rebecca L.

2014-01-01

Despite the national proliferation of technical assistance as a driver for school reform and as a model for embedded and sustained professional development, very little is known about the organizational structures and processes needed to support technical assistance. The purpose of this paper is to describe a structured needs assessment process…

Minnesota Deaf-Blind Technical Assistance Project. Final Report.

ERIC Educational Resources Information Center

Kloos, Eric

This final report describes activities and accomplishments of the 3-year federally supported Minnesota Deaf-Blind Technical Assistance Project. The project provided training and technical assistance, information sharing, and support services to families of children with deaf-blindness. Activities and accomplishments included: collaboration with…

76 FR 69612 - Amendment to the International Traffic in Arms Regulations: Sudan

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-09

... related technical training and assistance to monitoring, verification, or peace support operations... uses, and related technical training and assistance; (3) personal protective gear for the personal use... technical training and assistance to monitoring, verification, or peace support operations, including those...

75 FR 12740 - Wyoming Interstate Company, Inc.; Notice of Technical Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-17

... additional technical, engineering, and operational support for its proposed gas quality allocation procedures... should be prepared to support its position with adequate technical, engineering, and operational information. FERC conferences are accessible under section 508 of the Rehabilitation Act of 1973. For...

The Role of the Technical Specialist in Disaster Response and Recovery

NASA Astrophysics Data System (ADS)

Curtis, J. C.

2017-12-01

Technical Specialists provide scientific expertise for making operational decisions during natural hazards emergencies. Technical Specialists are important members of any Incident Management Team (IMT) as is described in in the National Incident Management System (NIMS) that has been designed to respond to emergencies. Safety for the responders and the threatened population is the foremost consideration in command decisions and objectives, and the Technical Specialist is on scene and in the command post to support and promote safety while aiding decisions for incident objectives. The Technical Specialist's expertise can also support plans, logistics, and even finance as well as operations. This presentation will provide actual examples of the value of on-scene Technical Specialists, using National Weather Service "Decision Support Meteorologists" and "Incident Meteorologists". These examples will demonstrate the critical role of scientists that are trained in advising and presenting life-critical analysis and forecasts during emergencies. A case will be made for local, state, and/or a national registry of trained and deployment-ready scientists that can support emergency response.

Scaffolding Collaborative Technical Writing with Procedural Facilitation and Synchronous Discussion

ERIC Educational Resources Information Center

Yeh, Shiou-Wen; Lo, Jia-Jiunn; Huang, Jeng-Jia

2011-01-01

With the advent of computer technology, researchers and instructors are attempting to devise computer support for effective collaborative technical writing. In this study, a computer-supported environment for collaborative technical writing was developed. This system (Process-Writing Wizard) provides process-oriented scaffolds and a synchronous…

USACE AIS Transmit Technical Support Summary Report

DTIC Science & Technology

2014-09-01

the TAG block for the correct transmitters, and then send to the USACE AIS network. B. Outbound openings in the USCG firewall for the USCG Message...USACE AIS Transmit Technical Support Summary Report Distribution Statement A: Approved for public release; distribution is unlimited...September 2014 Report No. CD-D-09-15 USACE AIS Transmit Technical Support Summary Report ii UNCLAS//Public | CG-926 RDC | I. Gonin et al. Public

Transforming South-South technical support to fight noncommunicable diseases.

PubMed

Shakow, Aaron D A; Bukhman, Gene; Adebona, Olumuyiwa; Greene, Jeremy; de Dieu Ngirabega, Jean; Binagwaho, Agnès

2012-03-01

At the UN High-Level Meeting on non-communicable diseases (NCD) in September 2011, each member state was challenged to create a multisectoral national policy and plan for the prevention and control of non-communicable disease by 2013. Few low-income countries, however, currently have such plans. Their governments are likely to turn for assistance in drafting and implementation to multilateral agencies and Contract Technical Support Organizations recommended by development partners. Yet because many NCD seen in the lowest-income countries differ significantly from those prevalent elsewhere, existing providers of external technical support may lack the necessary experience to support strategic planning for NCD interventions in these settings. This article reviews currently available mechanisms of technical support for health sector planning. It places them in the broader historical context of post- World War II international development assistance and the more recent campaigns for horizontal "South-South" cooperation and aid effectiveness. It proposes bilateral technical assistance by low income-countries themselves as the natural evolution of development assistance in health. Such programs, it argues, may be able to improve the quality of technical support to low-income countries for strategic planning in the NCD area while directing resources to the regions where they are most needed. Copyright © 2012 World Heart Federation (Geneva). Published by Elsevier B.V. All rights reserved.

A Theory of Sex Differences in Technical Aptitude and Some Supporting Evidence.

PubMed

Schmidt, Frank L

2011-11-01

In this article, I present a theory that explains the origin of sex differences in technical aptitudes. The theory takes as proven that there are no sex differences in general mental ability (GMA), and it postulates that sex differences in technical aptitude (TA) stem from differences in experience in technical areas, which is in turn based on sex differences in technical interests. Using a large data set, I tested and found support for four predictions made by this theory: (a) the construct level correlation between technical aptitude and GMA is larger for females than males, (b) the observed and true score variability of technical aptitude is greater among males than females, (c) at every level of GMA females have lower levels of technical aptitude, and (d) technical aptitude measures used as estimates of GMA for decision purposes would result in underestimation of GMA levels for girls and women. Given that GMA carries the weight of prediction of job performance, the support found for this last prediction suggests that, for many jobs, technical aptitude tests may underpredict the job performance of female applicants and employees. Future research should examine this question. © Association for Psychological Science 2011.

GROUND WATER TECHNICAL SUPPORT CENTER

EPA Science Inventory

EPA's Office of Research and Development operates a Ground Water Technical Support Center (GWTSC). The Center provides support on issues regarding subsurface contamination, contaminant fluxes to other media (e.g., surface water or air), and ecosystem restoration. The GWTSC creat...

2005 v4.3 Technical Support Document

EPA Pesticide Factsheets

Emissions Modeling for the Final Mercury and Air Toxics Standards Technical Support Document describes how updated 2005 NEI, version 2 emissions were processed for air quality modeling in support of the final Mercury and Air Toxics Standards (MATS).

Law tightened to protect adults who lack capacity.

PubMed

2009-05-21

VULNERABLE OLDER people will be better protected from abuse and poor care after new legislation came into force last month. Under the Mental Capacity Act Deprivation of Liberty Safeguards, a care home or hospital wanting to deprive a person who lacks capacity of their liberty, for their own safety or wellbeing, must now apply for permission. A rigorous, standardised assessment and authorisation process must then be completed.

Rituximab

PubMed Central

Storz, Ulrich

2014-01-01

Because drug development is not a static process, a drug’s market authorisation may change over time. In many cases, the number of indications for which a drug is approved increases. Because this facet of drug development also comes at significant costs, a corresponding patent filing strategy is required to protect these investments. The strategy as applied to rituximab, which is approved for a variety of indications, is discussed in this review. PMID:24866199

Caspofungin in the treatment of invasive fungal infections.

PubMed

Keady, Simon; Thacker, Meera

2006-02-01

Caspofungin is a member of a new class of antifungals called Echinocandins and is the first to have marketing authorisation in the United Kingdom. This article reviews the clinical efficacy, side effect profile, dosing and administration schedule of caspofungin. The article also discusses the warnings and precautions associated with the use of this drug. Caspofungin is an effective treatment option in the management of fungal infections.

Study protocol for a transversal study to develop a screening model for excessive gambling behaviours on a representative sample of users of French authorised gambling websites.

PubMed

Perrot, Bastien; Hardouin, Jean-Benoit; Costes, Jean-Michel; Caillon, Julie; Grall-Bronnec, Marie; Challet-Bouju, Gaëlle

2017-05-17

Since the legalisation of online gambling in France in 2010, gambling operators must implement responsible gambling measures to prevent excessive gambling practices. However, actually there is no screening procedure for identifying problematic gamblers. Although several studies have already been performed using several data sets from online gambling operators, the authors deplored several methodological and clinical limits that prevent scientifically validating the existence of problematic gambling behaviour. The aim of this study is to develop a model for screening excessive gambling practices based on the gambling behaviours observed on French gambling websites, coupled with a clinical validation. The research is divided into three successive stages. All analyses will be performed for each major type of authorised online gambling in France. The first stage aims at defining a typology of users of French authorised gambling websites based on their gambling behaviour. This analysis will be based on data from the Authority for Regulating Online Gambling (ARJEL) and the Française Des Jeux (FDJ). For the second stage aiming at determining a score to predict whether a gambler is problematic or not, we will cross answers from the Canadian Problem Gambling Index with real gambling data. The objective of the third stage is to clinically validate the score previously developed. Results from the screening model will be compared (using sensitivity, specificity, area under the curve, and positive and negative predictive values) with the diagnosis obtained with a telephone clinical interview, including diagnostic criteria for gambling addiction. This study was approved by the local Research Ethics Committee (GNEDS) on 25 March 2015. Results will be presented in national and international conferences, submitted to peer-reviewed journals and will be part of a PhD thesis. A final report with the study results will be presented to the ARJEL, especially the final screening model. NCT02415296. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Differentiated Technical Assistance for Sustainable Transformation. Technical Assistance Brief #2

ERIC Educational Resources Information Center

McCart, Amy; McSheehan, Michael; Sailor, Wayne

2015-01-01

Schoolwide Integrated Framework for Transformation (SWIFT) Center's technical assistance process supports states, districts, and schools as they become excellent and equitable teaching and learning environments for "all" students. Each school with support from its district begins this process from its own starting point and travels its…

31 CFR 543.301 - Arms or any related materiel.

Code of Federal Regulations, 2010 CFR

2010-07-01

... solely for humanitarian or protective use, and related technical assistance and training; (c) Supplies of... of arms and related materiel and technical training and assistance intended solely for support of or... technical assistance intended solely for the support of or use by the United Nations Operation in Côte d...

31 CFR 547.301 - Arms or any related materiel.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Supplies of arms and related materiel, technical training, and assistance intended solely for support of or... of arms and related materiel, technical training, and assistance described in paragraphs (a)(1... technical training and assistance intended solely for support of or use by MONUC; (c) Supplies of non-lethal...

Air Quality Modeling Technical Support Document for the Final Cross State Air Pollution Rule Update

EPA Pesticide Factsheets

In this technical support document (TSD) we describe the air quality modeling performed to support the final Cross State Air Pollution Rule for the 2008 ozone National Ambient Air Quality Standards (NAAQS).

78 FR 30233 - Defense Federal Acquisition Regulation Supplement; Government Support Contractor Access to...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

... Number 0750-AG38 Defense Federal Acquisition Regulation Supplement; Government Support Contractor Access... Government support contractors to have access to proprietary technical data belonging to prime contractors and other third parties, provided that the technical data owner may require the support contractor to...

Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

PubMed Central

Chapman, Kathryn; Adjei, Akosua; Baldrick, Paul; da Silva, Antonio; De Smet, Karen; DiCicco, Richard; Hong, Seung Suh; Jones, David; Leach, Michael W.; McBlane, James; Ragan, Ian; Reddy, Praveen; Stewart, Donald I. H.; Suitters, Amanda; Sims, Jennifer

2016-01-01

ABSTRACT Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of innovator monoclonal antibody (mAb) drugs have entered development as patents on these more complex proteins expire. In September 2013, the first biosimilar mAb, infliximab, was authorised in Europe. In March 2015, the first biosimilar (Zarxio™, filgrastim-sndz, Sandoz) was approved by the US Food and Drug Administration; however, to date no mAb biosimilars have been approved in the US. There are currently major differences between how biosimilars are regulated in different parts of the world, leading to substantial variability in the amount of in vivo nonclinical toxicity testing required to support clinical development and marketing of biosimilars. There are approximately 30 national and international guidelines on biosimilar development and this number is growing. The European Union's guidance describes an approach that enables biosimilars to enter clinical trials based on robust in vitro data alone; in contrast, the World Health Organization's guidance is interpreted globally to mean in vivo toxicity studies are mandatory. We reviewed our own experience working in the global regulatory environment, surveyed current practice, determined drivers for nonclinical in vivo studies with biosimilar mAbs and shared data on practice and study design for 25 marketed and as yet unmarketed biosimilar mAbs that have been in development in the past 5y. These data showed a variety of nonclinical in vivo approaches, and also demonstrated the practical challenges faced in obtaining regulatory approval for clinical trials based on in vitro data alone. The majority of reasons for carrying out nonclinical in vivo studies were not based on scientific rationale, and therefore the authors have made recommendations for a data-driven approach to the toxicological assessment of mAb biosimilars that minimises unnecessary use of animals and can be used across all regions of the world. PMID:26854177

The power of a collaborative relationship between technical assistance providers and community prevention teams: A correlational and longitudinal study.

PubMed

Chilenski, Sarah M; Perkins, Daniel F; Olson, Jonathan; Hoffman, Lesa; Feinberg, Mark E; Greenberg, Mark; Welsh, Janet; Crowley, D Max; Spoth, Richard

2016-02-01

Historically, effectiveness of community collaborative prevention efforts has been mixed. Consequently, research has been undertaken to better understand the factors that support their effectiveness; theory and some related empirical research suggests that the provision of technical assistance is one important supporting factor. The current study examines one aspect of technical assistance that may be important in supporting coalition effectiveness, the collaborative relationship between the technical assistance provider and site lead implementer. Four and one-half years of data were collected from technical assistance providers and prevention team members from the 14 community prevention teams involved in the PROSPER project. Spearman correlation analyses with longitudinal data show that the levels of the collaborative relationship during one phase of collaborative team functioning associated with characteristics of internal team functioning in future phases. Results suggest that community collaborative prevention work should consider the collaborative nature of the technical assistance provider - prevention community team relationship when designing and conducting technical assistance activities, and it may be important to continually assess these dynamics to support high quality implementation. Copyright © 2015 Elsevier Ltd. All rights reserved.

ERLN Technical Support for Labs

EPA Pesticide Factsheets

The Environmental Response Laboratory Network provides policies and guidance on lab and data requirements, Standardized Analytical Methods, and technical support for water and radiological sampling and analysis

Air Quality Modeling Technical Support Document for the 2008 Ozone NAAQS Cross-State Air Pollution Rule Proposal

EPA Pesticide Factsheets

In this technical support document (TSD) we describe the air quality modeling performed to support the proposed Cross-State Air Pollution Rule for the 2008 ozone National Ambient Air Quality Standards (NAAQS)

Air Quality Modeling Technical Support Document for the 2015 Ozone NAAQS Preliminary Interstate Transport Assessment

EPA Pesticide Factsheets

In this technical support document (TSD) EPA describes the air quality modeling performed to support the 2015 ozone National Ambient Air Quality Standards (NAAQS) preliminary interstate transport assessment Notice of Data Availability (NODA).

78 FR 45869 - Approval and Promulgation of State Implementation Plans; State of Montana; Interstate Transport...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-30

... of Montana's submission because the submission did not include any technical analysis to support its..., EPA disagrees with that concern. Our technical analysis confirmed that emissions from Montana in total... irrelevant factors and lacks any technical analysis to support the State's conclusion with respect to...

76 FR 14835 - Approval and Promulgation of Air Quality Implementation Plan; Missouri; Proposed Disapproval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... the state's conclusion should be supported by an adequate technical analysis. EPA recommended the...)(2)(D)(i)(I) must be supported by an adequate technical analysis.\\5\\ EPA recommended the various..., the state did not further evaluate or demonstrate with a technical analysis that these measures...

76 FR 43167 - Approval and Promulgation of Air Quality Implementation Plan; North Carolina; Disapproval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... stated that the state's conclusion should be supported by an adequate technical analysis. Second, EPA... revision must be supported by an adequate technical analysis, including, but not limited to, information... disapproval where the Agency states: ``* * * without an adequate technical analysis EPA does not believe that...

76 FR 14831 - Approval and Promulgation of Air Quality Implementation Plan; Kansas; Proposed Disapproval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... State's conclusion should be supported by an adequate technical analysis. EPA recommended the various...) must be supported by an adequate technical analysis.\\5\\ EPA recommended the various types of... evaluate or demonstrate with a technical analysis that these measures address the requirements of 110(a)(2...

76 FR 43159 - Approval and Promulgation of Air Quality Implementation Plan; Georgia; Disapproval of Interstate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... stated that the state's conclusion should be supported by an adequate technical analysis. Second, EPA...'' provisions, the state's SIP revision must be supported by an adequate technical analysis, including, but not..., proposed disapproval where the Agency states: ``* * * without an adequate technical analysis EPA does not...

76 FR 43128 - Approval and Promulgation of Air Quality Implementation Plan; Alabama; Disapproval of Interstate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

..., if so, address the impact. The state's conclusion must be supported by an adequate technical analysis...'' provisions, the state's SIP revision must be supported by an adequate technical analysis, including, but not... disapproval where the Agency states: ``* * *without an adequate technical analysis EPA does not believe that...

Design Study for Project on Standard Operating Procedures for Technical Library Services.

ERIC Educational Resources Information Center

Libbey, Miles A.; And Others

The overall objective of the Technical Information Support Activities (TISA) Project is the production of a "Post Commander's Handbook." The handbook will be instrumental in achieving greater utilization of available technical information resources to assist army scientists and engineers engaged in the support of army combat and other…

Computer Supported Education at Fox Valley Technical Institute. IBM Application Brief.

ERIC Educational Resources Information Center

International Business Machines Corp., White Plains, NY.

Fox Valley Technical Institute (FVTI) has developed an approach to education which emphasizes competency-based, round-the-clock education entailing short terms, flexible class schedules, and individualized instruction and which has as its focus strong computer support at classroom, technical, and management levels. The college provides 6,000…

Testing Services

NASA Technical Reports Server (NTRS)

1993-01-01

Trace Laboratories is an independent testing laboratory specializing in testing printed circuit boards, automotive products and military hardware. Technical information from NASA Tech Briefs and two subsequent JPL Technical Support packages have assisted Trace in testing surface insulation resistance on printed circuit board materials. Testing time was reduced and customer service was improved because of Jet Propulsion Laboratory technical support packages.

78 FR 78939 - 36(b)(1) Arms Sales Notification

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

... Quantity or Quantities of Articles or Services under Consideration for Purchase: C-130J technical, engineering and software support; software updates and patches; familiarization training for Portable Flight... and contractor technical support services; and other related elements of logistics and program support...

DNS load balancing in the CERN cloud

NASA Astrophysics Data System (ADS)

Reguero Naredo, Ignacio; Lobato Pardavila, Lorena

2017-10-01

Load Balancing is one of the technologies enabling deployment of large-scale applications on cloud resources. A DNS Load Balancer Daemon (LBD) has been developed at CERN as a cost-effective way to balance applications accepting DNS timing dynamics and not requiring persistence. It currently serves over 450 load-balanced aliases with two small VMs acting as master and slave. The aliases are mapped to DNS subdomains. These subdomains are managed with DDNS according to a load metric, which is collected from the alias member nodes with SNMP. During the last years, several improvements were brought to the software, for instance: support for IPv6, parallelization of the status requests, implementing the client in Python to allow for multiple aliases with differentiated states on the same machine or support for application state. The configuration of the Load Balancer is currently managed by a Puppet type. It discovers the alias member nodes and gets the alias definitions from the Ermis REST service. The Aiermis self-service GUI for the management of the LB aliases has been produced and is based on the Ermis service above that implements a form of Load Balancing as a Service (LBaaS). The Ermis REST API has authorisation based in Foreman hostgroups. The CERN DNS LBD is Open Software with Apache 2 license.

MNE7 Access to the Global Commons Outcome 3 Cyber Domain. Objective 3.5 Cyber Situational Awareness. Concept of Employment for Cyber Situational Awareness Within the Global Commons Version 1.0

DTIC Science & Technology

2013-02-25

such as authentication , protocols, and ‘signature’ management exist but the imposition of such techniques must be balan 15p the legal requirements...gulation, mation face onflicting pressures to keep this data secure and yet allow access by authorised users. in the sharing network should be

A General Comparison of SharePoint 2007 and SharePoint 2010

DTIC Science & Technology

2012-10-01

rich as some dedicated Wiki offerings, e.g. Confluence, appropriately authorised users can collaboratively develop content. Unlike Wiki pages...Workspace 2010 uses Windows credentials instead of a Groove-specific logon for authenticating users, thus improving consistency with the rest of the Office...environment, such as authentication properties. In SharePoint 2010 the Business Data Connectivity service is the new version of SharePoint 2007’s Business

Review of Data Integrity Models in Multi-Level Security Environments

DTIC Science & Technology

2011-02-01

2: (E-1 extension) Only executions described in a (User, TP, (CDIs)) relation are allowed • E-3: Users must be authenticated before allowing TP... authentication and verification procedures for upgrading the integrity of certain objects. The mechanism used to manage access to objects is primarily...that is, the self-consistency of interdependent data and the consistency of real-world environment data. The prevention of authorised users from making

Worldwide Report, Telecommunications Policy, Research and Development

DTIC Science & Technology

1985-12-31

3 Hong Kong Database Signs Contract With PRC (K. Gopinath; Hong Kong HONGKONG STANDARD, 18 Oct 85) .... 5 Briefs Hong Kong-London Data Link...KONG HONG KONG DATABASE SIGNS CONTRACT WITH PRC Hong Kong HONGKONG STANDARD in English Supplement 18 Oct 85 p 1 [Article by K. Gopinath] [Text...information group. The agreement between state-owned China Hua Yang Technology and Trade Corporation and DataBase Asia of Hong- kong, authorises

Can informed consent to research be adapted to risk?

PubMed

Bromwich, Danielle; Rid, Annette

2015-07-01

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the concern that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorisation. In this paper, we show how the standard view of informed consent--consent as autonomous authorisation--can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A look back at 2009: one step forward, two steps back.

PubMed

2010-04-01

In 2009, we examined 104 new brand name products or new indications for existing products in the French edition of Prescrire. Only 3 of these 104 "innovations" provided some therapeutic advantage, while 19 had clearly unfavourable risk-benefit balances. Marketing authorisations are failing to adequately protect patients. A number of cheaper generic versions of useful drugs were introduced to the market, while BigPharma's anticompetitive practices were aimed at slowing the growth of generics manufacturers. The quality of over-the-counter drugs marketed for self-medication, especially "umbrella" brands, left much to be desired. Consumer protection is clearly not the primary concern of the European (EMA) and French (Afssaps) drug regulatory agencies. They remain too financially dependent on drug companies; hesitate to withdraw dangerous drugs from the market; and withhold drug safety data. Other signs of drug companies' excessive influence, at patients' expense, include drug pricing that bears little relation to therapeutic advantage (in oncology, for example); the financial dependence of many patient groups on drug companies; the European Commission's attempts to authorise direct-to-consumer advertising and to allow the pharmaceutical sector to tighten its grip on health information, including pharmacovigilance data. Governments must assume their responsibilities, and patients and the healthcare profession must resist BigPharma's increasing involvement in all spheres of patient care.

Development and validation of rapid multiresidue and multi-class analysis for antibiotics and anthelmintics in feed by ultra-high-performance liquid chromatography coupled to tandem mass spectrometry.

PubMed

Robert, Christelle; Brasseur, Pierre-Yves; Dubois, Michel; Delahaut, Philippe; Gillard, Nathalie

2016-08-01

A new multi-residue method for the analysis of veterinary drugs, namely amoxicillin, chlortetracycline, colistins A and B, doxycycline, fenbendazole, flubendazole, ivermectin, lincomycin, oxytetracycline, sulfadiazine, tiamulin, tilmicosin and trimethoprim, was developed and validated for feed. After acidic extraction, the samples were centrifuged, purified by SPE and analysed by ultra-high-performance liquid chromatography coupled to tandem mass spectrometry. Quantitative validation was done in accordance with the guidelines laid down in European Commission Decision 2002/657/CE. Matrix-matched calibration with internal standards was used to reduce matrix effects. The target level was set at the authorised carryover level (1%) and validation levels were set at 0.5%, 1% and 1.5%. Method performances were evaluated by the following parameters: linearity (0.986 < R(2) < 0.999), precision (repeatability < 12.4% and reproducibility < 14.0%), accuracy (89% < recovery < 107%), sensitivity, decision limit (CCα), detection capability (CCβ), selectivity and expanded measurement uncertainty (k = 2).This method has been used successfully for three years for routine monitoring of antibiotic residues in feeds during which period 20% of samples were found to exceed the 1% authorised carryover limit and were deemed non-compliant.

The european paediatric legislation: benefits and perspectives

PubMed Central

2010-01-01

Background The lack of availability of appropriate medicines for children is an extensive and well known problem. Paediatricians and Physicians who take care of the paediatric population are primarily exposed to cope with this negative situation very often as more than half of the children are prescribed off-label or unlicensed medicines. Discussion Medicinal products used to treat this population should be subjected to ethical research of high quality and be explicitly authorised for use in children as it happens in adults. For that reason, and following the US experience, the European Paediatric Regulation has been amended in January 2007 by the European Commission. The objective of the Paediatric Regulation is to improve the development of high quality and ethically researched medicines for children aged 0 to 17 years, to facilitate the availability of information on the use of medicines for children, without subjecting children to unnecessary trials, or delaying the authorisation of medicines for use in adults. Summary The Paediatric Regulation is dramatically changing the regulatory environment for paediatric medicines in Europe and is fuelling an increased number of clinical trials in the paediatric population. Nevertheless, there are some risks and pitfalls that need to be anticipated and controlled in order to ensure that children will ultimately benefit from this European initiative. PMID:20716337

76 FR 4579 - Approval and Promulgation of Air Quality Implementation Plan; New Jersey and New York...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... supported by an adequate technical analysis. EPA recommended the various types of information that could be...) must be supported by an adequate technical analysis. In the 2009 Guidance, EPA recommended the various...) because the State did not evaluate or demonstrate with a technical analysis that the emissions reduction...

76 FR 4584 - Approval and Promulgation of Air Quality Implementation Plans; Georgia; Disapproval of Interstate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... conclusion must be supported by an adequate technical analysis. Second, EPA recommended the various types of... requirement of section 110(a)(2)(D)(i)(I) must be supported by an adequate technical analysis. Additionally... evaluate or demonstrate with a technical analysis that this measure and their intention to rely to the...

78 FR 11124 - EPA Responses to State and Tribal 2010 Sulfur Dioxide Designation Recommendations: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-15

... supporting technical analyses, can be found on the EPA's Internet Web site at http://www.epa.gov... you for clarification due to technical difficulties, the EPA may not be able to consider your input... possible in supporting your views. Describe any assumptions and provide any technical information and/or...

Engineering Technical Support Center Annual Report Fiscal Year 2014; Technical Support and Innovative Research for Contaminated Sites

EPA Science Inventory

This report highlights significant projects that the ETSC has supported throughout fiscal year 2014. Projects have addressed an array of environmental scenarios, including but not limited to remote mining contamination, expansive landfill waste, sediment remediation by capping, ...

Urban Rail Supporting Technology Program Fiscal Year 1974 Year End Summary

DOT National Transportation Integrated Search

1975-03-01

Major areas include program management, technical support and application engineering, facilities development, test and evaluation, and technology development. Specific technical discussion includes track measurement systems; UMTA facilities developm...

Solar Technical Assistance Team Webinars | State, Local, and Tribal

Science.gov Websites

Governments | NREL Solar Technical Assistance Team Webinars Solar Technical Assistance Team Webinars NREL's Solar Technical Assistance Team (STAT), with support from the U.S. Department of Energy

Effects of Demographic Characteristics, Educational Background, and Supporting Factors on ICT Readiness of Technical and Vocational Teachers in Malaysia

ERIC Educational Resources Information Center

Alazzam, Abu-Obaideh; Bakar, Ab Rahim; Hamzah, Ramlah; Asimiran, S.

2012-01-01

The aim of this study was to examine ICT readiness and the effects of demographic characteristics, educational background, and support factors on the ICT readiness of technical and vocational teachers in Malaysia. The questionnaire was administered to 329 technical and vocational teachers who are teaching engineering subjects in Malaysian…

Engineering Technical Support Center Annual Report Fiscal Year 2013; Technical Support and Innovative Research for Contaminated Sites

EPA Science Inventory

This report summarizes a variety of significant projects that the ETSC, located in the Land Remediation and Pollution Control Division (LRPCD), National Risk Management Research Laboratory (NRMRL), has supported throughout fiscal year 2013. Projects have addressed an array of env...

Technical Support Services for the Office of Naval Research Littoral Warfare Advanced Development Project

DTIC Science & Technology

2005-09-30

Technical Support Services for the Office of Naval Research Littoral Warfare Advanced Development Project William R. Metzger Marine...Support Services for the Office of Naval Research Littoral Warfare Advanced Development Project 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT

77 FR 28393 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

... Support Post Earthquake Reconstruction, Cholera and HIV/AIDS Response, FOA GH12-001, and Research and Technical Assistance for Public Health Laboratories in Haiti to Support Post Earthquake Reconstruction... and Technical Assistance for Public Health Interventions in Haiti to Support Post Earthquake...

Advance decision.

PubMed

Samuels, Alec; Barrister, J P

2007-10-01

In the UK, patients have a statutory right to refuse treatment. Parliament has authorised 'advance decision' whereby a person can specify his or her wishes regarding further medical treatment. Although the advance decision may give a person peace of mind, it could create real problems for doctors and other healthcare professionals. This article will examine the conditions and procedures surrounding the drawing up of an advance decision as well as some of the problems that could arise such as layman's language.

New Capabilities in Security and QoS Using the Updated MANET Routing Protocol OLSRv2

DTIC Science & Technology

2010-09-01

integrity, by the authentication of packets or messages, and confidentiality. These are discussed in the following sections. Issues of availability...fully specified, in [2] is the addition of a TLV including a cryptographic signature that will allow the authentication of the received information...The objective is to ensure the integrity of the ad hoc network, that only authorised routers can join the network because unauthorised routers will

Planning a DSN support section technical library

NASA Technical Reports Server (NTRS)

Bailey, T.; Chatburn, C. C.

1980-01-01

The planning procedure being used to establish a technical library for the Deep Space Network support section is described. The inventory and survey methods employed are described and the preliminary results of these methods are discussed.

Draft federal GHG accounting and reporting : technical support document

DOT National Transportation Integrated Search

2010-07-01

This is a technical support document (TSD) that accompanies the Federal Greenhouse Gas Accounting and Reporting Guidance (or Guidance). This document provides detailed information on the inventory reporting process and accepted calculation methodolog...

The coevolution of innovation and technical intelligence in primates

PubMed Central

Street, Sally E.; Whalen, Andrew; Laland, Kevin N.

2016-01-01

In birds and primates, the frequency of behavioural innovation has been shown to covary with absolute and relative brain size, leading to the suggestion that large brains allow animals to innovate, and/or that selection for innovativeness, together with social learning, may have driven brain enlargement. We examined the relationship between primate brain size and both technical (i.e. tool using) and non-technical innovation, deploying a combination of phylogenetically informed regression and exploratory causal graph analyses. Regression analyses revealed that absolute and relative brain size correlated positively with technical innovation, and exhibited consistently weaker, but still positive, relationships with non-technical innovation. These findings mirror similar results in birds. Our exploratory causal graph analyses suggested that technical innovation shares strong direct relationships with brain size, body size, social learning rate and social group size, whereas non-technical innovation did not exhibit a direct relationship with brain size. Nonetheless, non-technical innovation was linked to brain size indirectly via diet and life-history variables. Our findings support ‘technical intelligence’ hypotheses in linking technical innovation to encephalization in the restricted set of primate lineages where technical innovation has been reported. Our findings also provide support for a broad co-evolving complex of brain, behaviour, life-history, social and dietary variables, providing secondary support for social and ecological intelligence hypotheses. The ability to gain access to difficult-to-extract, but potentially nutrient-rich, resources through tool use may have conferred on some primates adaptive advantages, leading to selection for brain circuitry that underlies technical proficiency. PMID:26926276

The coevolution of innovation and technical intelligence in primates.

PubMed

Navarrete, Ana F; Reader, Simon M; Street, Sally E; Whalen, Andrew; Laland, Kevin N

2016-03-19

In birds and primates, the frequency of behavioural innovation has been shown to covary with absolute and relative brain size, leading to the suggestion that large brains allow animals to innovate, and/or that selection for innovativeness, together with social learning, may have driven brain enlargement. We examined the relationship between primate brain size and both technical (i.e. tool using) and non-technical innovation, deploying a combination of phylogenetically informed regression and exploratory causal graph analyses. Regression analyses revealed that absolute and relative brain size correlated positively with technical innovation, and exhibited consistently weaker, but still positive, relationships with non-technical innovation. These findings mirror similar results in birds. Our exploratory causal graph analyses suggested that technical innovation shares strong direct relationships with brain size, body size, social learning rate and social group size, whereas non-technical innovation did not exhibit a direct relationship with brain size. Nonetheless, non-technical innovation was linked to brain size indirectly via diet and life-history variables. Our findings support 'technical intelligence' hypotheses in linking technical innovation to encephalization in the restricted set of primate lineages where technical innovation has been reported. Our findings also provide support for a broad co-evolving complex of brain, behaviour, life-history, social and dietary variables, providing secondary support for social and ecological intelligence hypotheses. The ability to gain access to difficult-to-extract, but potentially nutrient-rich, resources through tool use may have conferred on some primates adaptive advantages, leading to selection for brain circuitry that underlies technical proficiency. © 2016 The Author(s).

7 CFR 653.3 - Adaptation of technical standards.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 6 2012-01-01 2012-01-01 false Adaptation of technical standards. 653.3 Section 653.3..., DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL STANDARDS § 653.3 Adaptation of technical standards. Technical standards and criteria developed on a national basis may require special adaptation to meet local...

7 CFR 653.3 - Adaptation of technical standards.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 6 2014-01-01 2014-01-01 false Adaptation of technical standards. 653.3 Section 653.3..., DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL STANDARDS § 653.3 Adaptation of technical standards. Technical standards and criteria developed on a national basis may require special adaptation to meet local...

7 CFR 653.3 - Adaptation of technical standards.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 6 2011-01-01 2011-01-01 false Adaptation of technical standards. 653.3 Section 653.3..., DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL STANDARDS § 653.3 Adaptation of technical standards. Technical standards and criteria developed on a national basis may require special adaptation to meet local...

7 CFR 653.3 - Adaptation of technical standards.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 6 2013-01-01 2013-01-01 false Adaptation of technical standards. 653.3 Section 653.3..., DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL STANDARDS § 653.3 Adaptation of technical standards. Technical standards and criteria developed on a national basis may require special adaptation to meet local...

Technical support for Life Sciences communities on a production grid infrastructure.

PubMed

Michel, Franck; Montagnat, Johan; Glatard, Tristan

2012-01-01

Production operation of large distributed computing infrastructures (DCI) still requires a lot of human intervention to reach acceptable quality of service. This may be achievable for scientific communities with solid IT support, but it remains a show-stopper for others. Some application execution environments are used to hide runtime technical issues from end users. But they mostly aim at fault-tolerance rather than incident resolution, and their operation still requires substantial manpower. A longer-term support activity is thus needed to ensure sustained quality of service for Virtual Organisations (VO). This paper describes how the biomed VO has addressed this challenge by setting up a technical support team. Its organisation, tooling, daily tasks, and procedures are described. Results are shown in terms of resource usage by end users, amount of reported incidents, and developed software tools. Based on our experience, we suggest ways to measure the impact of the technical support, perspectives to decrease its human cost and make it more community-specific.

32 CFR 203.10 - Eligible activities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... with technical reports that summarize data and support cleanup decisions. Technical assistance may be provided to review plans and interpret technical reports for community members of RABs and TRCs. These...) MISCELLANEOUS TECHNICAL ASSISTANCE FOR PUBLIC PARTICIPATION (TAPP) IN DEFENSE ENVIRONMENTAL RESTORATION...

32 CFR 203.10 - Eligible activities.

Code of Federal Regulations, 2014 CFR

2014-07-01

... with technical reports that summarize data and support cleanup decisions. Technical assistance may be provided to review plans and interpret technical reports for community members of RABs and TRCs. These...) MISCELLANEOUS TECHNICAL ASSISTANCE FOR PUBLIC PARTICIPATION (TAPP) IN DEFENSE ENVIRONMENTAL RESTORATION...

32 CFR 203.10 - Eligible activities.

Code of Federal Regulations, 2012 CFR

2012-07-01

... with technical reports that summarize data and support cleanup decisions. Technical assistance may be provided to review plans and interpret technical reports for community members of RABs and TRCs. These...) MISCELLANEOUS TECHNICAL ASSISTANCE FOR PUBLIC PARTICIPATION (TAPP) IN DEFENSE ENVIRONMENTAL RESTORATION...

Geotechnical support and topical studies for nuclear waste geologic repositories

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1989-01-01

The present report lists the technical reviews and comments made during the fiscal year 1988 and summarizes the technical progress of the topical studies. In the area of technical assistance, there were numerous activities detailed in the next section. These included 24 geotechnical support activities, including reviews of 6 Study Plans (SP) and participation in 6 SP Review Workshops, review of one whole document Site Characterization Plan (SCP) and participation in the Assembled Document SCP Review Workshops by 6 LBL reviewers; the hosting of a DOE program review, the rewriting of the project statement of work, 2 trips to technicalmore » and planning meetings; preparation of proposed work statements for two new topics for DOE, and 5 instances of technical assistance to DOE. These activities are described in a Table in the following section entitled Geoscience Technical Support for Nuclear Waste Geologic Repositories.''« less

Engineering Technical Support Center, Innovative Science and Technical Support for Cost-Effective Cleanups: Five Year Summary Report for 2007-2012

EPA Science Inventory

This report summarizes a variety of significant projects that ETSC and its colleagues in the Land Remediation and Pollution Control Division (LRPCD) have supported during the last five years. Projects have addressed an array of environmental scenarios, including remote mining co...

USAF/SCEEE Graduate Student Summer Support Program (1982). Management and Technical Report.

DTIC Science & Technology

1982-10-01

AD-A130 767 USAF/SCEEE GRADUATE STUDENT SUMMER SUPPORT PROGRAM (1982) MANAGEMENT AND..(U) SOUTHEASTERN CENTER FORELECTRICAL ENGINEERING EDUCATION INC...SUMMER SUPPORT PROGRAM Conducted by Southeastern Center for Electrical Engineering Education under USAF Contract Number F49620-82-C-0035 MANAGEMENT ...UNITED STATES AIR FORCE GRADUATE STUDENT SL24MER SUPPORT PROGRAM 1982 PROGRAM MANAGEMENT AND TECHNICAL REPORT SOUTHEASTERN CENTER FOR ELECTRICAL

Quality user support: Supporting quality users

DOE Office of Scientific and Technical Information (OSTI.GOV)

Woolley, T.C.

1994-12-31

During the past decade, fundamental changes have occurred in technical computing in the oil industry. Technical computing systems have moved from local, fragmented quantity, to global, integrated, quality. The compute power available to the average geoscientist at his desktop has grown exponentially. Technical computing applications have increased in integration and complexity. At the same time, there has been a significant change in the work force due to the pressures of restructuring, and the increased focus on international opportunities. The profile of the user of technical computing resources has changed. Users are generally more mature, knowledgeable, and team oriented than theirmore » predecessors. In the 1990s, computer literacy is a requirement. This paper describes the steps taken by Oryx Energy Company to address the problems and opportunities created by the explosive growth in computing power and needs, coupled with the contraction of the business. A successful user support strategy will be described. Characteristics of the program include: (1) Client driven support; (2) Empowerment of highly skilled professionals to fill the support role; (3) Routine and ongoing modification to the support plan; (4) Utilization of the support assignment to create highly trained advocates on the line; (5) Integration of the support role to the reservoir management team. Results of the plan include a highly trained work force, stakeholder teams that include support personnel, and global support from a centralized support organization.« less

The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists.

PubMed

Merks, Piotr; Swieczkowski, Damian; Byliniak, Michal; Drozd, Mariola; Krupa, Katarzyna; Jaguszewski, Milosz; Brindley, David A; Naughton, Bernard D

2018-01-01

By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law and whether or not these actions are sufficient. We found that Poland is only partially compliant with the FMD and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland about the prevalence of falsified medication and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD.

Geospatial application for the identification and monitoring of rubber smallholders in the Malaysian state of Negeri Sembilan

NASA Astrophysics Data System (ADS)

Hafiz Mohd Hazir, Mohd; Muda, Tuan Mohamad Tuan

2016-06-01

The Malaysian rubber industry, especially in the upstream sector, is much dependent on smallholders to produce latex or cup lumps. Identification and monitoring of rubber smallholders are essential tasks when it comes to the Malaysian rubber industry's sustainability. The authorised agencies who support the rubber smallholders can do better planning, arranging, and managing. This paper introduces a method of calculating the total number of smallholders as well as identifying the location of their planted rubber area. The scope of this study only focused on land owners as rubber smallholders in the selected study area of Negeri Sembilan. The land use map provided by the Department of Agriculture Malaysia gave information on distribution of rubber area in Malaysia, while the cadastral map from the Department of Survey and Mapping Malaysia was specifically used for identifying land owners of each rubber parcel or rubber lot. Both data were analyzed and processed with ArcGIS software to extract the information, and the results were then compared to the Malaysian Rubber Board smallholders database.

The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists

PubMed Central

Merks, Piotr; Swieczkowski, Damian; Byliniak, Michal; Drozd, Mariola; Krupa, Katarzyna; Jaguszewski, Milosz; Brindley, David A; Naughton, Bernard D

2018-01-01

By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law and whether or not these actions are sufficient. We found that Poland is only partially compliant with the FMD and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland about the prevalence of falsified medication and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD. PMID:29445453

The new era of postgraduate certified general practice training in Japan.

PubMed

Takamura, Akiteru

2016-09-01

This paper describes the background to, and the recent evolution of general practice as a recognised medical specialism in Japan (2015), and the evolution of a system of training to support this development. We, the general practitioners (GPs) in Japan have not been recognised as one body of medical specialists and have been training in our own way. A new certified training system will commence in 2018, authorised by a new third organisation, the Japanese Medical Specialty Board. An effective educational system has been developed for medical graduates that have a career intention in general practice that is distinct from other basic medical fields, but collaborates with them. A challenge exists to provide clarity to the Japanese population about what the specialty of general practice is, and what professionals in general practice can do for them. Japan currently has approximately 500 certified GPs and it is unclear at present what numbers will eventually be required. This paper reviews some of the challenges facing the development of general practice from the perspective of the Japan Primary Care Association.

European grid services for global earth science

NASA Astrophysics Data System (ADS)

Brewer, S.; Sipos, G.

2012-04-01

This presentation will provide an overview of the distributed computing services that the European Grid Infrastructure (EGI) offers to the Earth Sciences community and also explain the processes whereby Earth Science users can engage with the infrastructure. One of the main overarching goals for EGI over the coming year is to diversify its user-base. EGI therefore - through the National Grid Initiatives (NGIs) that provide the bulk of resources that make up the infrastructure - offers a number of routes whereby users, either individually or as communities, can make use of its services. At one level there are two approaches to working with EGI: either users can make use of existing resources and contribute to their evolution and configuration; or alternatively they can work with EGI, and hence the NGIs, to incorporate their own resources into the infrastructure to take advantage of EGI's monitoring, networking and managing services. Adopting this approach does not imply a loss of ownership of the resources. Both of these approaches are entirely applicable to the Earth Sciences community. The former because researchers within this field have been involved with EGI (and previously EGEE) as a Heavy User Community and the latter because they have very specific needs, such as incorporating HPC services into their workflows, and these will require multi-skilled interventions to fully provide such services. In addition to the technical support services that EGI has been offering for the last year or so - the applications database, the training marketplace and the Virtual Organisation services - there now exists a dynamic short-term project framework that can be utilised to establish and operate services for Earth Science users. During this talk we will present a summary of various on-going projects that will be of interest to Earth Science users with the intention that suggestions for future projects will emerge from the subsequent discussions: • The Federated Cloud Task Force is already providing a cloud infrastructure through a few committed NGIs. This is being made available to research communities participating in the Task Force and the long-term aim is to integrate these national clouds into a pan-European infrastructure for scientific communities. • The MPI group provides support for application developers to port and scale up parallel applications to the global European Grid Infrastructure. • A lively portal developer and provider community that is able to setup and operate custom, application and/or community specific portals for members of the Earth Science community to interact with EGI. • A project to assess the possibilities for federated identity management in EGI and the readiness of EGI member states for federated authentication and authorisation mechanisms. • Operating resources and user support services to process data with new types of services and infrastructures, such as desktop grids, map-reduce frameworks, GPU clusters.

Flood control project selection using an interval type-2 entropy weight with interval type-2 fuzzy TOPSIS

NASA Astrophysics Data System (ADS)

Zamri, Nurnadiah; Abdullah, Lazim

2014-06-01

Flood control project is a complex issue which takes economic, social, environment and technical attributes into account. Selection of the best flood control project requires the consideration of conflicting quantitative and qualitative evaluation criteria. When decision-makers' judgment are under uncertainty, it is relatively difficult for them to provide exact numerical values. The interval type-2 fuzzy set (IT2FS) is a strong tool which can deal with the uncertainty case of subjective, incomplete, and vague information. Besides, it helps to solve for some situations where the information about criteria weights for alternatives is completely unknown. Therefore, this paper is adopted the information interval type-2 entropy concept into the weighting process of interval type-2 fuzzy TOPSIS. This entropy weight is believed can effectively balance the influence of uncertainty factors in evaluating attribute. Then, a modified ranking value is proposed in line with the interval type-2 entropy weight. Quantitative and qualitative factors that normally linked with flood control project are considered for ranking. Data in form of interval type-2 linguistic variables were collected from three authorised personnel of three Malaysian Government agencies. Study is considered for the whole of Malaysia. From the analysis, it shows that diversion scheme yielded the highest closeness coefficient at 0.4807. A ranking can be drawn using the magnitude of closeness coefficient. It was indicated that the diversion scheme recorded the first rank among five causes.

Technical Support Project for Cleaning Up Contaminated Sites - Expertise Directory

EPA Pesticide Factsheets

This directory is searchable and provides a snapshot of the various types of expertise possessed by the current members of the three Technical Support Project forums. It is based on input provided by the members themselves.

76 FR 68429 - 36(b)(1) Arms Sales Notification

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-04

... documentation, U.S. Government and contractor engineering, technical, and logistics personnel support services, and other related elements of logistics support. (iv) Military Department: Navy (USMC) (SDH). (v.... Government and contractor engineering, technical, and logistics personnel [[Page 68432

Technical Support Document for Title V Permitting of Printing Facilities

EPA Pesticide Factsheets

Stationary source emissions monitoring is required to demonstrate that a source is meeting the requirements in Federal or state rules, including Title V. This document provides the technical support for compliance in the printing and publishing industry.

AHMCT Intelligent Roadway Information System (IRIS) technical support and testing

DOT National Transportation Integrated Search

2011-12-31

This report documents the research project AHMCT IRIS Technical Support and Testing, : performed under contract 65A0275, Task ID 1777. It presents an overview of the Intelligent : Roadway Information System (IRIS), and its design and function. ...

AHMCT Intelligent Roadway Information System (IRIS) technical support and testing.

DOT National Transportation Integrated Search

2011-12-01

This report documents the research project AHMCT IRIS Technical Support and Testing, : performed under contract 65A0275, Task ID 1777. It presents an overview of the Intelligent : Roadway Information System (IRIS), and its design and function. ...

A systems approach to implementation of eLearning in medical education: five MEPI schools' journeys.

PubMed

Vovides, Yianna; Chale, Selamawit Bedada; Gadhula, Rumbidzayi; Kebaetse, Masego B; Nigussie, Netsanet Animut; Suleman, Fatima; Tibyampansha, Dativa; Ibrahim, Glory Ramadhan; Ntabaye, Moshi; Frehywot, Seble; Nkomazana, Oathokwa

2014-08-01

How should eLearning be implemented in resource-constrained settings? The introduction of eLearning at four African medical schools and one school of pharmacy, all part of the Medical Education Partnership Initiative (MEPI) eLearning Technical Working Group, highlighted the need for five factors essential for successful and sustainable implementation: institutional support; faculty engagement; student engagement; technical expertise; and infrastructure and support systems. All five MEPI schools reported strengthening technical expertise, infrastructure, and support systems; four schools indicated that they were also successful in developing student engagement; and three reported making good progress in building institutional support. Faculty engagement was the one core component that all five schools needed to enhance.

External Technical Support for School Improvement: Critical Issues from the Chilean Experience

ERIC Educational Resources Information Center

Osses, Alejandra; Bellei, Cristián; Valenzuela, Juan Pablo

2015-01-01

To what extent school improvement processes can be initiated and sustained from the outside has been a relevant question for policy-makers seeking to increase quality in education. Since 2008, the Chilean Government is strongly promoting the use of external technical support (ETS) services to support school improvement processes, as part of the…

The Development of the Command and Control Centre for Trial Kondari

DTIC Science & Technology

2010-07-01

the C2 centre inside a blue bubble whose modems have privately assigned IP addresses which are authenticated by Telstra’s radius server. No other sim...cards can communicate on this private network unless authorised by the radius server. The Next IP network is a network bubble within the larger Next...for all machines on the network.  EPLRS Network Manager (ENM) radio – authenticates and manages all the EPLRS radios. The basic plan’s final

Results from a post-launch monitoring survey on consumer purchases of foods with added phytosterols in five European countries.

PubMed

Willems, Julie I; Blommaert, Mireille A E; Trautwein, Elke A

2013-12-01

Phytosterols (plant sterols and stanols), in the form of phytosterol-esters, are used in food products as active ingredients to lower elevated blood low density lipoprotein-cholesterol concentrations. In Europe, plant sterol-esters gained Novel Foods authorisation in 2000. As a requirement of the authorisation, Unilever developed a post-launch monitoring program to monitor the use of products with added phytosterols. This paper reports findings from the 2011 post-launch monitoring survey on consumer purchase behaviour of foods with added phytosterols. 91,000 households in the Netherlands, Belgium, United Kingdom, France and Germany were included. 11,612 purchased foods with added phytosterols, including spreads, salad dressings, milk- and yoghurt-type products. The results show that 71-82% of households purchasing products with added phytosterols were 1-2 person households. These households were also purchasing the majority of the volume sold in each country (75-85%). The average phytosterol intakes per household were 0.35-0.86 g/day; well below the 1.5-3.0 g/day phytosterols needed to achieve a significant blood cholesterol lowering benefit. Post-launch monitoring is an accepted and useful tool to estimate the consumption behaviour amongst different consumer groups. Data show that average phytosterol intakes per household were well below 1g/day, suggesting that overconsumption is unlikely. Copyright © 2013 Elsevier Ltd. All rights reserved.

Applications Where Snap is BPM for Radioactive Waste Assay

DOE Office of Scientific and Technical Information (OSTI.GOV)

Miller, T.J.

2008-07-01

Historically, the Atomic Weapons Establishment (AWE) at Aldermaston in the United Kingdom (UK), has used a variety of assay techniques to measure the radioactive content of a diverse range of waste packages from decommissioning, operational and legacy sources. The regulator, the Environment Agency in the UK, places conditions and limits on AWE through an authorisation within the Radioactive Substances Act (RSA93). The conditions and limits require Best Practical Means (BPM) measurements to be used to demonstrate compliance with the authorisation. Hence, the assay technique employed needs to achieve a balance between risk of exposure, environmental considerations, technological considerations, health andmore » safety considerations and cost effectiveness, without being grossly disproportionate in terms of money, time or trouble. Recently published work has concluded that the Spectral Non-destructive Assay Platform (SNAP) assay system is BPM for Depleted Uranium (DU) waste assay at AWE (1) and low level plutonium in soft drummed waste, HEPA filters and soils (2-4). The purpose of this paper is to highlight other applications where SNAP represents BPM for radioactive waste assay. This has been done by intercomparison studies of SNAP with other assay techniques, such as Segmented Gamma Scanner (SGS) and Passive Neutron Coincidence Counter (PNCC). It has been concluded that, for a large range of waste packages encountered at AWE, SNAP is BPM. (author)« less

The potential application of European market research data in dietary exposure modelling of food additives.

PubMed

Tennant, David Robin; Bruyninckx, Chris

2018-03-01

Consumer exposure assessments for food additives are incomplete without information about the proportions of foods in each authorised category that contain the additive. Such information has been difficult to obtain but the Mintel Global New Products Database (GNPD) provides information about product launches across Europe over the past 20 years. These data can be searched to identify products with specific additives listed on product labels and the numbers compared with total product launches for food and drink categories in the same database to determine the frequency of occurrence. There are uncertainties associated with the data but these can be managed by adopting a cautious and conservative approach. GNPD data can be mapped with authorised food categories and with food descriptions used in the EFSA Comprehensive European Food Consumption Surveys Database for exposure modelling. The data, when presented as percent occurrence, could be incorporated into the EFSA ANS Panel's 'brand-loyal/non-brand loyal exposure model in a quantitative way. Case studies of preservative, antioxidant, colour and sweetener additives showed that the impact of including occurrence data is greatest in the non-brand loyal scenario. Recommendations for future research include identifying occurrence data for alcoholic beverages, linking regulatory food codes, FoodEx and GNPD product descriptions, developing the use of occurrence data for carry-over foods and improving understanding of brand loyalty in consumer exposure models.

78 FR 2449 - Office of Small Credit Unions (OSCUI) Grant Program Access for Credit Unions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-11

... availability. The OSCUI Grant Program serves as a source of financial support, in the form of technical... provides financial support in the form of technical assistance grants to LICUs. These funds help improve...

77 FR 52698 - 36(b)(1) Arms Sales Notification

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... training equipment, publications and technical data, U.S. Government and contractor technical and logistics personnel services and other related elements of program and logistics support. (iv) Military Department..., publications and technical data, U.S. Government and contractor technical and logistics personnel services and...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gauglitz, Phillip A.; Bontha, Jagannadha R.; Daniel, Richard C.

The Hanford Waste Treatment and Immobilization Plant (WTP) is currently being designed and constructed to pretreat and vitrify a large portion of the waste in the 177 underground waste storage tanks at the Hanford Site. A number of technical issues related to the design of the pretreatment facility (PTF) of the WTP have been identified. These issues must be resolved prior to the U.S. Department of Energy (DOE) Office of River Protection (ORP) reaching a decision to proceed with engineering, procurement, and construction activities for the PTF. One of the issues is Technical Issue T1 - Hydrogen Gas Release frommore » Vessels (hereafter referred to as T1). The focus of T1 is identifying controls for hydrogen release and completing any testing required to close the technical issue. In advance of selecting specific controls for hydrogen gas safety, a number of preliminary technical studies were initiated to support anticipated future testing and to improve the understanding of hydrogen gas generation, retention, and release within PTF vessels. These activities supported the development of a plan defining an overall strategy and approach for addressing T1 and achieving technical endpoints identified for T1. Preliminary studies also supported the development of a test plan for conducting testing and analysis to support closing T1. Both of these plans were developed in advance of selecting specific controls, and in the course of working on T1 it was decided that the testing and analysis identified in the test plan were not immediately needed. However, planning activities and preliminary studies led to significant technical progress in a number of areas. This report summarizes the progress to date from the preliminary technical studies. The technical results in this report should not be used for WTP design or safety and hazards analyses and technical results are marked with the following statement: “Preliminary Technical Results for Planning – Not to be used for WTP Design or Safety Analyses.”« less

The Independent Technical Analysis Process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Duberstein, Corey A.; Ham, Kenneth D.; Dauble, Dennis D.

2007-04-13

The Bonneville Power Administration (BPA) contracted with the Pacific Northwest National Laboratory (PNNL) to provide technical analytical support for system-wide fish passage information (BPA Project No. 2006-010-00). The goal of this project was to produce rigorous technical analysis products using independent analysts and anonymous peer reviewers. In the past, regional parties have interacted with a single entity, the Fish Passage Center to access the data, analyses, and coordination related to fish passage. This project provided an independent technical source for non-routine fish passage analyses while allowing routine support functions to be performed by other well-qualified entities.

7 CFR 652.6 - Department delivery of technical services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 6 2010-01-01 2010-01-01 false Department delivery of technical services. 652.6... CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.6 Department delivery of technical services. (a) The Department may enter into a...

7 CFR 652.4 - Technical service standards.

Code of Federal Regulations, 2010 CFR

2010-01-01

... technologies and practices. (c) A technical service provider must assume responsibility in writing for the... 7 Agriculture 6 2010-01-01 2010-01-01 false Technical service standards. 652.4 Section 652.4..., DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.4...

Technical Assistance Needs Assessments (TANAs)

EPA Pesticide Factsheets

The Technical Assistance Needs Assessment (TANA) is a process to identify whether a community requires additional support from EPA in order to understand technical information and have meaningful participation in the Superfund decision-making process.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Green, D.W.; Heinrich, R.R.; Jensen, K.J.

Technical and administrative activities of the Analytical Chemistry Laboratory (ACL) are reported for fiscal year 1984. The ACL is a full-cost-recovery service center, with the primary mission of providing a broad range of technical support services to the scientific and engineering programs at ANL. In addition, ACL conducts a research program in analytical chemistry, works on instrumental and methods development, and provides analytical services for governmental, educational, and industrial organizations. The ACL is administratively within the Chemical Technology Division, the principal user, but provides technical support for all of the technical divisions and programs at ANL. The ACL has threemore » technical groups - Chemical Analysis, Instrumental Analysis, and Organic Analysis. Under technical activities 26 projects are briefly described. Under professional activities, a list is presented for publications and reports, oral presentations, awards and meetings attended. 6 figs., 2 tabs.« less

A Socio-technical Approach for Transient SME Alliances

NASA Astrophysics Data System (ADS)

Rezgui, Yacine

The paper discusses technical requirements to promote the adoption of alliance modes of operation by SMEs in the construction sector. These requirements have provided a basis for specifying a set of functionality to support the collaboration and cooperation needs of SMEs. While service-oriented architectures and semantic web services provide the middleware technology to implement the identified functionality, a number of key technical limitations have been identified, including lack of support for the dynamic and non-functional characteristics of SME alliances distributed business processes, lack of execution monitoring functionality to manage running business processes, and lack of support for semantic reasoning to enable SME business process service composition. The paper examines these issues and provides key directions for supporting SME alliances effectively.

Technical requirements for bioassay support services

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hickman, D.P.; Anderson, A.L.

1991-05-01

This document provides the technical basis for the Chem-Nuclear Geotech (Geotech) bioassay program. It includes information and details that can be used as a model in providing technical contents and requirements for bioassay laboratory support, either internally or in solicitations by Geotech to obtain subcontractor laboratory support. It provides a detailed summary and description of the types of bioassay samples to be expected in support of Geotech remedial projects for the US Department of Energy and the bioassay services and analytical requirements necessary to process such samples, including required limits of sensitivity. General responsibilities of the bioassay laboratory are alsomore » addressed, including quality assurance. Peripheral information of importance to the program is included in the appendices of this document. 7 tabs.« less

34 CFR 300.702 - Technical assistance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 2 2010-07-01 2010-07-01 false Technical assistance. 300.702 Section 300.702 Education..., and Use of Funds § 300.702 Technical assistance. (a) In general. The Secretary may reserve not more... to support technical assistance activities authorized under section 616(i) of the Act. (b) Maximum...

Site Characterization and Monitoring Technical Support Center FY16 Report

EPA Science Inventory

SCMTSC’s primary goal is to provide technical assistance to regional programs on complex hazardous waste site characterization issues. This annual report illustrates the range and extent of projects that SCMTSC supported in FY 2016. Our principal audiences are site project manage...

Impact of electronic clinical decision support on adherence to guideline-recommended treatment for hyperlipidaemia, atrial fibrillation and heart failure: protocol for a cluster randomised trial

PubMed Central

Kessler, Maya Elizabeth; Cook, David A; Kor, Daryl Jon; McKie, Paul M; Pencille, Laurie J; Scheitel, Marianne R; Chaudhry, Rajeev

2017-01-01

Introduction Clinical practice guidelines facilitate optimal clinical practice. Point of care access, interpretation and application of such guidelines, however, is inconsistent. Informatics-based tools may help clinicians apply guidelines more consistently. We have developed a novel clinical decision support tool that presents guideline-relevant information and actionable items to clinicians at the point of care. We aim to test whether this tool improves the management of hyperlipidaemia, atrial fibrillation and heart failure by primary care clinicians. Methods/analysis Clinician care teams were cluster randomised to receive access to the clinical decision support tool or passive access to institutional guidelines on 16 May 2016. The trial began on 1 June 2016 when access to the tool was granted to the intervention clinicians. The trial will be run for 6 months to ensure a sufficient number of patient encounters to achieve 80% power to detect a twofold increase in the primary outcome at the 0.05 level of significance. The primary outcome measure will be the percentage of guideline-based recommendations acted on by clinicians for hyperlipidaemia, atrial fibrillation and heart failure. We hypothesise care teams with access to the clinical decision support tool will act on recommendations at a higher rate than care teams in the standard of care arm. Ethics and dissemination The Mayo Clinic Institutional Review Board approved all study procedures. Informed consent was obtained from clinicians. A waiver of informed consent and of Health Insurance Portability and Accountability Act (HIPAA) authorisation for patients managed by clinicians in the study was granted. In addition to publication, results will be disseminated via meetings and newsletters. Trial registration number NCT02742545. PMID:29208620

Implementation of quality improvement techniques for management and technical processes in the ACRV project

NASA Technical Reports Server (NTRS)

Raiman, Laura B.

1992-01-01

Total Quality Management (TQM) is a cooperative form of doing business that relies on the talents of everyone in an organization to continually improve quality and productivity, using teams and an assortment of statistical and measurement tools. The objective of the activities described in this paper was to implement effective improvement tools and techniques in order to build work processes which support good management and technical decisions and actions which are crucial to the success of the ACRV project. The objectives were met by applications in both the technical and management areas. The management applications involved initiating focused continuous improvement projects with widespread team membership. The technical applications involved applying proven statistical tools and techniques to the technical issues associated with the ACRV Project. Specific activities related to the objective included working with a support contractor team to improve support processes, examining processes involved in international activities, a series of tutorials presented to the New Initiatives Office and support contractors, a briefing to NIO managers, and work with the NIO Q+ Team. On the technical side, work included analyzing data from the large-scale W.A.T.E.R. test, landing mode trade analyses, and targeting probability calculations. The results of these efforts will help to develop a disciplined, ongoing process for producing fundamental decisions and actions that shape and guide the ACRV organization .

Implementation of quality improvement techniques for management and technical processes in the ACRV project

NASA Astrophysics Data System (ADS)

Raiman, Laura B.

1992-12-01

Total Quality Management (TQM) is a cooperative form of doing business that relies on the talents of everyone in an organization to continually improve quality and productivity, using teams and an assortment of statistical and measurement tools. The objective of the activities described in this paper was to implement effective improvement tools and techniques in order to build work processes which support good management and technical decisions and actions which are crucial to the success of the ACRV project. The objectives were met by applications in both the technical and management areas. The management applications involved initiating focused continuous improvement projects with widespread team membership. The technical applications involved applying proven statistical tools and techniques to the technical issues associated with the ACRV Project. Specific activities related to the objective included working with a support contractor team to improve support processes, examining processes involved in international activities, a series of tutorials presented to the New Initiatives Office and support contractors, a briefing to NIO managers, and work with the NIO Q+ Team. On the technical side, work included analyzing data from the large-scale W.A.T.E.R. test, landing mode trade analyses, and targeting probability calculations. The results of these efforts will help to develop a disciplined, ongoing process for producing fundamental decisions and actions that shape and guide the ACRV organization .

Clinical success of implant-supported and tooth-implant-supported double crown-retained dentures.

PubMed

Bernhart, Gunda; Koob, Andreas; Schmitter, Marc; Gabbert, Olaf; Stober, Thomas; Rammelsberg, Peter

2012-08-01

The objective of this retrospective study was to compare biological and technical complications of implant-supported and tooth-implant-supported double crown-retained dentures (DCRDs) with those of tooth-supported DCRDs. Sixty-three DCRDs were monitored. One study group included 16 prostheses with a combination of implants and natural teeth as double crowns (ti group), whereas in the second study group, 19 dentures were retained exclusively on implants (ii group); a third study group with 28 exclusively tooth-supported dentures served as controls (tt group). Tooth loss, implant failure, and technical complications (loss of retention of primary crown, abutment screw loosening, loss of facing, fracture of resin denture teeth and fracture of saddle resin) were analysed. During the observation period of 24 months, no implants or teeth were lost in the ti group and three technical complications were recorded. In the ii group, two implants were lost, two cases of peri-implantitis occurred and four technical complications were observed. In the tt group, two cases of tooth loss and seven technical complications were observed. At the time of the last examination, all prostheses of the ti group and the ii group were functional. Patients of these two study groups reported high satisfaction with both function and aesthetics with no significant difference between the two groups. Treatment with DCRDs showed comparable results in the three study groups. The 2-year results indicate that double crowns can be recommended for implant and combined tooth-implant-retained dentures.

Technical challenges involved in supporting the Lambda Point Experiment

NASA Technical Reports Server (NTRS)

Petrac, D.; Israelsson, U.; Otth, D.; Simmons, L.; Staats, J.; Thompson, A.

1990-01-01

The Lambda Point Experiment (LPE) is one of the instruments included in the U.S. Microgravity Payload Mission 1 planned for one of the Space Shuttle flights in 1992. The objective of the experiment is to measure the heat capacity of liquid helium within a narrow interval around the transition between superfluid and normal helium (the lambda point) with an unprecedented temperature resolution of about 10 to the -10th. Multiple technical challenges are presented in the areas of structural support, safety analysis, and modal frequency tests. This paper describes the technical challenges of JPL's multidisciplinary involvement in support of these experiments in microgravity.

ICU staffing: identification and survey of staff involved in providing technical support services to Australian and New Zealand intensive care units.

PubMed

Carter, B G; Kiraly, N; Hochmann, M; Stephens, R; Osborne, A

2007-04-01

We conducted a survey of all (200) Australian and New Zealand intensive care units to determine the presence and nature of staff employed in a technical support role. Specifically, we attempted to identify staff who are formally employed in a role where they are directly responsible for the equipment used in intensive care. Of 130 returned surveys, 80 units (62%) reported not having any personnel in this role. In these units technical tasks were most commonly performed by registered nurses (79%) but were also performed by a variety of other personnel. Fifty units (38%), consisting of approximately 105 individuals providing a total of 84.3 EFTs and most commonly in public (84%) or metropolitan (70%) hospitals or level 3 (64%) intensive care units, did have one or more staff acting in a formal technical support role. The most common groups filling the technical support role were nurses (42%), technicians (24%), biomedical engineers (10%) and technologists (6%). The most common duties performed were equipment troubleshooting (92%), training (80%), equipment evaluation (80%), ordering supplies (77%), consumable evaluation (75%), equipment cleaning (73%), delivery of supplies (70%), handling product recalls (65%), equipment maintenance (65%) and sitting on hospital committees (52%). This is the first attempt to identify and understand the technical support role in Australian and New Zealand intensive care units. Numerous issues remain and future work will hopefully add to our findings, with the possibility of formal recognition of the role, training and/or accreditation and its extension into other hospital departments.

[Skin necrosis resulting from the extravasation of intravenous injections].

PubMed

Ikhefoulma, Soumaya; Mahiou, Abelhamid; Perillat, Isabelle

2012-09-01

Extravasation is the diffusion of a product injected intravenously into the perivascular or subcutaneous spaces. Skin necrosis of iatrogenic origin can be observed for example with a subcutaneous perfusion of solution containing potassium chloride or the extravasation of 30% hypertonic glucose serum. Whenever a product is injected, the administration route for which the product has obtained marketing authorisation must be respected and a perfusion time of at least 4 to 5 hours per litre of solution perfused must be observed.

System M: A Program Logic for Code Sandboxing and Identification

DTIC Science & Technology

2014-07-22

M. Ryan. Attack, solution and verification for shared authorisation data in TCG TPM. In Proc. FAST’09, 2010. [8] A. Datta, A. Derek, J. C. Mitchell...11] S. Delaune, S. Kremer, M. D. Ryan, and G. Steel. A formal analysis of authentication in the TPM. In Proc. FAST’10, 2011. [12] S. Delaune, S...A. Jeffrey. Authenticity by typing for security protocols. Journal of Computer Security, 11(4):451–519, July 2003. [16] S. Gürgens, C. Rudolph, D

Innovative Socio-Technical Environments in Support of Distributed Intelligence and Lifelong Learning

ERIC Educational Resources Information Center

Fischer, G; Konomi, S.

2007-01-01

Individual, unaided human abilities are constrained. Media have helped us to transcend boundaries in thinking, working, learning and collaborating by supporting "distributed intelligence". Wireless and mobile technologies provide new opportunities for creating novel socio-technical environments and thereby empowering humans, but not without…

ERD WATERSHED AND WATER QUALITY MODEL DEVELOPMENT AND TECHNICAL SUPPORT PROGRAM

EPA Science Inventory

The ERD has a long history in providing model research and development and technical support to Regions, States and the Office of Water for watersheds/water quality ecosystem research. The ERD efforts are described in major subtasks comprising the Program. Briefly, these are:

78 FR 36538 - 36(b)(1) Arms Sales Notification

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-18

... training equipment, U.S. Government and contractor engineering, technical and logistics support services... equipment, U.S. Government and contractor engineering, technical and logistics support services, and other... central government and the country's outlying areas. The sale of these C-130Js to Libya will significantly...

EPA Technical Support Centers (TSC): FY14 Lessons Learned

EPA Science Inventory

EPA’s Technical Support Centers (TSC) included in ORD’s Safe and Healthy Communities (SHC) Research Action Plan fill the need for supplying subject-matter experts to continually assess state-of-the-art research and practices and channel this information to users in both direct ap...

75 FR 27227 - Energy Conservation Program: Energy Conservation Standards for Residential Central Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-14

... that DOE could consider for these products. DOE also encouraged written comments on these subjects... conservation standards notice of public meeting (NOPM) and availability of the preliminary technical support... Federal Register notice announcing the availability of its preliminary technical support document for...

76 FR 17573 - Energy Conservation Standards for Commercial Refrigeration Equipment: Public Meeting and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-30

... Preliminary Technical Support Document AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of public meeting and availability of preliminary technical support document... refrigeration equipment. In addition, DOE encourages written comments on these subjects. To inform interested...

Groundwater Technical Support Center (GWTSC) Annual Report Fiscal Year 2016 (FY16)

EPA Science Inventory

The Groundwater Technical Support Center (GWTSC) is part of the Groundwater, Watershed, and Ecosystem Restoration Division (GWERD), which is based in the Robert S. Kerr Environmental Research Center in Ada, Oklahoma. The GWERD is a research division of EPA’s National Risk M...

78 FR 20503 - Energy Conservation Program: Availability of the Interim Technical Support Document for High...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... Conservation Program: Availability of the Interim Technical Support Document for High-Intensity Discharge Lamps... high-intensity discharge (HID) lamps energy conservation standards in the Federal Register. This... interim analysis for high- intensity discharge lamps energy conservation standards. The notice provided...

76 FR 43175 - Approval of Air Quality Implementation Plans; Indiana and Ohio; Disapproval of Interstate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... impact. EPA stated that the state's conclusion should be supported by an adequate technical analysis. EPA... by an adequate technical analysis. IDEM did not provide a technical analysis in its submittal, but... technical analysis and justification necessary to make that demonstration. Indiana did not provide any...

Head Start Impact Study. Technical Report

ERIC Educational Resources Information Center

Puma, Michael; Bell, Stephen; Cook, Ronna; Heid, Camilla; Shapiro, Gary; Broene, Pam; Jenkins, Frank; Fletcher, Philip; Quinn, Liz; Friedman, Janet; Ciarico, Janet; Rohacek, Monica; Adams, Gina; Spier, Elizabeth

2010-01-01

This Technical Report is designed to provide technical detail to support the analysis and findings presented in the "Head Start Impact Study Final Report" (U.S. Department of Health and Human Services, January 2010). Chapter 1 provides an overview of the Head Start Impact Study and its findings. Chapter 2 provides technical information on the…

Ground Water Technical Support Center (GWTSC) Annual Report Fiscal Year 2014 (FY14)

EPA Science Inventory

The Ground Water Technical Support Center (GWTSC) is part of the Ground Water and Ecosystems Restoration Division (GWERD), which is based in the Robert S. Kerr Environmental Research Center in Ada, Oklahoma. The GWERD is a research division of U.S. EPA's National Risk Management...

Ground Water Technical Support Center (GWTSC) Annual Report Fiscal Year 2015

EPA Science Inventory

The Ground Water Technical Support Center (GWTSC) is part of the Ground Water and Ecosystems Restoration Division (GWERD), which is based in the Robert S. Kerr Environmental Research Center in Ada, Oklahoma. The GWERD is a research division of U.S. EPA’s National Risk Management ...

76 FR 67194 - Administration on Children, Youth and Families Announces the Award of a Single-Source Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

... Support Expanded Training and Technical Assistance to the Pennsylvania Coalition Against Domestic Violence... and Services Act (FVPSA) Technical Assistance (TA) Project. CFDA Number: 93.592. Statutory Authority... Domestic Violence in Harrisburg, PA. The supplemental funds will support the grantee in providing training...

75 FR 56021 - Energy Conservation Standards for Battery Chargers and External Power Supplies: Public Meeting...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-15

... Preliminary Technical Support Document AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of public meeting and availability of preliminary technical support document... that DOE could consider for these products. DOE also encourages interested parties to submit written...

75 FR 14319 - Energy Conservation Standards for Fluorescent Lamp Ballasts: Public Meeting and Availability of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... Technical Support Document AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of public meeting and availability of preliminary technical support document. SUMMARY: The... products. DOE encourages written comments on these subjects. To inform interested parties and facilitate...

76 FR 18127 - Energy Conservation Standards for Metal Halide Lamp Fixtures: Public Meeting and Availability of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

... Technical Support Document AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of public meeting and availability of preliminary technical support document. SUMMARY: The... for this equipment. DOE encourages written comments on these subjects. To inform interested parties...

77 FR 43015 - Energy Conservation Standards for Commercial and Industrial Electric Motors: Public Meeting and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-23

... Motors: Public Meeting and Availability of the Preliminary Technical Support Document AGENCY: Office of... availability of preliminary technical support document. SUMMARY: The U.S. Department of Energy (DOE or... consider for this equipment. DOE also encourages interested parties to submit written comments on these...

77 FR 13026 - Energy Conservation Program: Energy Conservation Standard for Automatic Commercial Ice Makers

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-05

... written comments on these subjects. This document announces an extension of the time period for submitting... preliminary technical support document (preliminary TSD) for automatic commercial ice makers. The comment... published a Federal Register notice announcing the availability of its preliminary technical support...

77 FR 3404 - Energy Conservation Standards for Automatic Commercial Ice Makers: Public Meeting and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-24

... Technical Support Document AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of public meeting and availability of preliminary technical support document. SUMMARY: The... commercial ice makers. In addition, DOE encourages written comments on these subjects. To inform interested...

75 FR 17080 - Energy Conservation Standards for Walk-in Coolers and Walk-in Freezers: Public Meeting and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-05

... Preliminary Technical Support Document AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of public meeting and availability of preliminary technical support document... consider for this equipment. In addition, DOE encourages written comments on these subjects. To inform...

77 FR 40530 - Energy Conservation Standards for Residential Furnace Fans: Public Meeting and Availability of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... Technical Support Document AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of public meeting and availability of preliminary technical support document. SUMMARY: The... furnace fans. In addition, DOE encourages written comments on these subjects. To inform interested parties...

34 CFR 380.6 - What activities may the Secretary fund under technical assistance supported employment projects?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Department of Education (Continued) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION SPECIAL PROJECTS AND DEMONSTRATIONS FOR PROVIDING SUPPORTED EMPLOYMENT SERVICES TO INDIVIDUALS... 34 Education 2 2010-07-01 2010-07-01 false What activities may the Secretary fund under technical...

(Review Draft) Radiation Site Cleanup Regulations: Technical Support Document For The Development Of Radionuclide Cleanup Levels For Soil

EPA Pesticide Factsheets

This document describes parts of the technical analysis being undertaken in support of standards that ensure certain sites are cleaned up to a level that is protective of human health and the environment before they are released for public use.

Technical assessment of PSSC-supported experiments and demonstrations

NASA Technical Reports Server (NTRS)

1978-01-01

A description of CTS and ATS short-term and long-term satellite demonstration supported through usage of a satellite communication ground station complex is presented. User assessments about the programmatic impact of their demonstrations and experiments were summarized. The technical planning and coordination process involved in satellite utilization is also presented.

ITS/CVO technical project management for non-technical managers : participant guide

DOT National Transportation Integrated Search

1998-09-01

In 1996, the FHWA Office of Motor Carriers (OMC) identified the need to develop a Technical Training Program to support the deployment of Intelligent Transportation System (ITS) technologies for Commercial Vehicle Operations (CVO). The workforce -...

7 CFR 652.36 - Appeal of decertification decisions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... technical service provider's written appeal, the Chief or his designee, will make a final determination, in... CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE... of the State Conservationist's decertification determination, the technical service provider may...

Principles and Procedures in Technical Assistance: An Approach to Educational Change

ERIC Educational Resources Information Center

Lillie, David L.; Black, Talbot

1976-01-01

The Technical Assistance Development System (TADS) has developed through the years a system for technical assistance and has identified some important principles that should be followed in the operation of organizational support systems. (Author/ER)

Technical assistance from state health departments for communities engaged in policy, systems, and environmental change: the ACHIEVE Program.

PubMed

Hefelfinger, Jenny; Patty, Alice; Ussery, Ann; Young, Walter

2013-10-24

This study assessed the value of technical assistance provided by state health department expert advisors and by the staff of the National Association of Chronic Disease Directors (NACDD) to community groups that participated in the Action Communities for Health, Innovation, and Environmental Change (ACHIEVE) Program, a CDC-funded health promotion program. We analyzed quantitative and qualitative data reported by community project coordinators to assess the nature and value of technical assistance provided by expert advisors and NACDD staff and the usefulness of ACHIEVE resources in the development and implementation of community action plans. A grounded theory approach was used to analyze and categorize phrases in text data provided by community coordinators. Open coding placed conceptual labels on text phrases. Frequency distributions of the quantitative data are described and discussed. The most valuable technical assistance and program support resources were those determined to be in the interpersonal domain (ie, interactions with state expert advisors, NACDD staff, and peer-to-peer support). The most valuable technical assistance events were action institutes, coaches' meetings, webinars, and technical assistance conference calls. This analysis suggests that ACHIEVE communities valued the management and training assistance provided by expert advisors and NACDD staff. State health department expert advisors provided technical guidance and support, including such skills or knowledge-based services as best-practice strategies, review and discussion of community assessment data, sustainability planning, and identification of possible funding opportunities. NACDD staff led development and implementation of technical assistance events.

Technical Support Document for Version 3.9.1 of the COMcheck Software

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bartlett, Rosemarie; Connell, Linda M.; Gowri, Krishnan

2012-09-01

COMcheck provides an optional way to demonstrate compliance with commercial and high-rise residential building energy codes. Commercial buildings include all use groups except single family and multifamily not over three stories in height. COMcheck was originally based on ANSI/ASHRAE/IES Standard 90.1-1989 (Standard 90.1-1989) requirements and is intended for use with various codes based on Standard 90.1, including the Codification of ASHRAE/IES Standard 90.1-1989 (90.1-1989 Code) (ASHRAE 1989a, 1993b) and ASHRAE/IESNA Standard 90.1-1999 (Standard 90.1-1999). This includes jurisdictions that have adopted the 90.1-1989 Code, Standard 90.1-1989, Standard 90.1-1999, or their own code based on one of these. We view Standard 90.1-1989more » and the 90.1-1989 Code as having equivalent technical content and have used both as source documents in developing COMcheck. This technical support document (TSD) is designed to explain the technical basis for the COMcheck software as originally developed based on the ANSI/ASHRAE/IES Standard 90.1-1989 (Standard 90.1-1989). Documentation for other national model codes and standards and specific state energy codes supported in COMcheck has been added to this report as appendices. These appendices are intended to provide technical documentation for features specific to the supported codes and for any changes made for state-specific codes that differ from the standard features that support compliance with the national model codes and standards. Beginning with COMcheck version 3.8.0, support for 90.1-1989, 90.1-1999, and the 1998 IECC and version 3.9.0 support for 2000 and 2001 IECC are no longer included, but those sections remain in this document for reference purposes.« less

AACE: an innovative partnership to enhance aircraft safety

NASA Astrophysics Data System (ADS)

Shurtleff, William W.

1999-01-01

The Federal Aviation Administration established the Airworthiness Assurance Center of Excellence (AACE) in September 1997, through a cooperative agreement grant with Iowa State University (ISU) and The Ohio State University (OSU). A technical support contract with the Center is now in place as well. Initially the Center has five areas of concentration supporting advances in airworthiness assurance. These are 1. Maintenance, inspection, and repair, 2. Propulsion and fuel systems safety, 3. Crashworthiness, 4. Advanced materials, and 5. Landing gear systems performance and safety. AACE has nine core members who provide guidance to the Program Management Office at ISU/OSU through a Board of Directors. The core members are: Arizona State University, Iowa State University, Northwestern University, The Ohio State University, University of Dayton, University of Maryland, University of California - Los Angeles, Wichita State University, and Sandia National Laboratories. The organization also includes numerous academic affiliates, industry partners, government laboratories and other organizations. The Center now has over thirty technical projects supporting technical advances in airworthiness assurance. All these projects have industry guidance and support. This paper discusses the current technical program of the center and the highlights of the five-year plan for technical work. Also included is a description of the factors that make the Center an innovative partnership to promote aircraft safety.

Space station attached payload program support

NASA Technical Reports Server (NTRS)

Estes, Maurice G., Jr.; Brown, Bardle D.

1989-01-01

The USRA is providing management and technical support for the peer review of the Space Station Freedom Attached Payload proposals. USRA is arranging for consultants to evaluate proposals, arranging meeting facilities for the reviewers to meet in Huntsville, Alabama and management of the actual review meetings. Assistance in developing an Experiment Requirements Data Base and Engineering/Technical Assessment support for the MSFC Technical Evaluation Team is also being provided. The results of the project will be coordinated into a consistent set of reviews and reports by USRA. The strengths and weaknesses analysis provided by the peer panel reviewers will by used NASA personnel in the selection of experiments for implementation on the Space Station Freedom.

Technical Assistance to Developers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rockward, Tommy; Borup, Rodney L.; Garzon, Fernando H.

2012-07-17

This task supports the allowance of technical assistance to fuel-cell component and system developers as directed by the DOE. This task includes testing of novel materials and participation in the further development and validation of single cell test protocols. This task also covers technical assistance to DOE Working Groups, the U.S. Council for Automotive Research (USCAR) and the USCAR/DOE Driving Research and Innovation for Vehicle efficiency and Energy sustainability (U.S. Drive) Fuel Cell Technology Team. Assistance includes technical validation of new fuel cell materials and methods, single cell fuel cell testing to support the development of targets and test protocols,more » and regular advisory participation in other working groups and reviews. This assistance is made available to PEM fuel cell developers by request and DOE Approval. The objectives are to: (1) Support technically, as directed by DOE, fuel cell component and system developers; (2) Assess fuel cell materials and components and give feedback to developers; (3) Assist the DOE Durability Working Group with the development of various new material durability Testing protocols; and (4) Provide support to the U.S. Council for Automotive Research (USCAR) and the USCAR/DOE Fuel Cell Technology Team. FY2012 specific technical objectives are: (1) Evaluate novel MPL materials; (2) Develop of startup/ shutdown protocol; (3) Test the impact of hydrophobic treatment on graphite bi-polar plates; (4) Perform complete diagnostics on metal bi-polar plates for corrosion; and (5) Participate and lead efforts in the DOE Working Groups.« less

7 CFR 652.21 - Certification criteria and requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... must: (1) Have the required technical training, education, and experience to perform the level of technical assistance for which certification is sought; (2) Meet any applicable professional or business... CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE...

Small Potatoes No More.

ERIC Educational Resources Information Center

Ries, Eric

2000-01-01

Idaho has improved its historically poor career and technical education programs by changing priorities and increasing state support. A large grant from the J.A. and Kathryn Albertson Foundation is being used to develop professional-technical academies and to train career and technical teachers. (JOW)

7 CFR 652.3 - Administration.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.3 Administration. (a) As provided in this part, the Department will provide technical assistance to participants directly, or at the option of the participant, through a technical service provider in accordance with the...

7 CFR 652.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.2 Definitions... public agencies certified by NRCS to provide technical services to a participant. Certification means the... technical service for conservation planning or a specific conservation practice or system; or (2) An entity...

Development of Hydrogen Education Programs for Government Officials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Baxter, Shannon; Keller, Russ

1. Subcontractor/Technical Subject Matter Expert (Tasks 1-3) 2. Technical lead for LFG cleanup and hydrogen production systems Support for Feasibility Study 3. Technical Lead for Feasibility Study Coordination of site preparation activities for all project equipment 4. Host site

47 CFR 80.659 - Technical requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Technical requirements. 80.659 Section 80.659 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Maritime Support Stations § 80.659 Technical requirements. The authorized frequency...

Exploring the Capability of Evaluating Technical Solutions: A Collaborative Study into the Primary Technology Classroom

ERIC Educational Resources Information Center

Björkholm, Eva

2014-01-01

Within the field of technology education, evaluating technical solutions is considered as an important topic. Research indicates that pupils have difficulties in evaluating technical solutions in terms of fitness for purpose, i.e. how effective a technical solution supports its intended function. By using the learning study, which is an iterative…

Pesticide exposure assessment for surface waters in the EU. Part 1: Some comments on the current procedure.

PubMed

Bach, Martin; Diesner, Mirjam; Großmann, Dietlinde; Guerniche, Djamal; Hommen, Udo; Klein, Michael; Kubiak, Roland; Müller, Alexandra; Priegnitz, Jan; Reichenberger, Stefan; Thomas, Kai; Trapp, Matthias

2016-07-01

In 2001, the European Commission introduced a risk assessment project known as FOCUS (FOrum for the Coordination of pesticide fate models and their USe) for the surface water risk assessment of active substances in the European Union. Even for the national authorisation of plant protection products (PPPs), the vast majority of EU member states still refer to the four runoff and six drainage scenarios selected by the FOCUS Surface Water Workgroup. However, our study, as well as the European Food Safety Authority (EFSA), has stated the need for various improvements. Current developments in pesticide exposure assessment mainly relate to two processes. Firstly, predicted environmental concentrations (PECs) of pesticides are calculated by introducing model input variables such as weather conditions, soil properties and substance fate parameters that have a probabilistic nature. Secondly, spatially distributed PECs for soil-climate scenarios are derived on the basis of an analysis of geodata. Such approaches facilitate the calculation of a spatiotemporal cumulative distribution function (CDF) of PECs for a given area of interest and are subsequently used to determine an exposure concentration endpoint as a given percentile of the CDF. For national PPP authorisation, we propose that, in the future, exposure endpoints should be determined from the overall known statistical PEC population for an area of interest, and derived for soil and climate conditions specific to the particular member state. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

Standardized reporting for rapid relative effectiveness assessments of pharmaceuticals.

PubMed

Kleijnen, Sarah; Pasternack, Iris; Van de Casteele, Marc; Rossi, Bernardette; Cangini, Agnese; Di Bidino, Rossella; Jelenc, Marjetka; Abrishami, Payam; Autti-Rämö, Ilona; Seyfried, Hans; Wildbacher, Ingrid; Goettsch, Wim G

2014-11-01

Many European countries perform rapid assessments of the relative effectiveness (RE) of pharmaceuticals as part of the reimbursement decision making process. Increased sharing of information on RE across countries may save costs and reduce duplication of work. The objective of this article is to describe the development of a tool for rapid assessment of RE of new pharmaceuticals that enter the market, the HTA Core Model® for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals. Eighteen member organisations of the European Network of Health Technology Assessment (EUnetHTA) participated in the development of the model. Different versions of the model were developed and piloted in this collaboration and adjusted accordingly based on feedback on the content and feasibility of the model. The final model deviates from the traditional HTA Core Model® used for assessing other types of technologies. This is due to the limited scope (strong focus on RE), the timing of the assessment (just after market authorisation), and strict timelines (e.g. 90 days) required for performing the assessment. The number of domains and assessment elements was limited and it was decided that the primary information sources should preferably be a submission file provided by the marketing authorisation holder and the European Public Assessment Report. The HTA Core Model® for Rapid REA (version 3.0) was developed to produce standardised transparent RE information of pharmaceuticals. Further piloting can provide input for possible improvements, such as further refining the assessment elements and new methodological guidance on relevant areas.

Catumaxomab: malignant ascites: unjustified marketing authorisation.

PubMed

2010-10-01

The only treatment for malignant ascites in patients with refractory cancer is paracentesis, a procedure to relieve symptoms. Catumaxomab, a monoclonal antibody, is now authorised in the European Union for intraperitoneal administration to patients with epithelial cancers that overexpress epithelial cellular adhesion molecule (EpCAM) and provoke ascites unresponsive to chemotherapy. Clinical evaluation of catumaxomab in this setting is based on a comparative, randomised but unblinded trial including 258 patients. Patients in the catumaxomab group had four paracenteses over a 10-day period, followed by a 6-hour intraperitoneal catumaxomab infusion, while patients in the control group had a single paracentesis. Catumaxomab did not extend median survival time, which was about two months. Methodological biases rule out any conclusions as to whether catumaxomab reduced the number of paracenteses needed during this short survival period. In this trial, 80% of patients treated with catumaxomab experienced serious adverse events, versus 29% of controls, resulting in hospitalisation in respectively about 29% versus 16% of patients. Two-thirds of patients had reactions linked to intraperitoneal catumaxomab infusion. Gastrointestinal disorders were frequent, and included abdominal pain, nausea and vomiting. Catumaxomab is hepatotoxic. In addition, most patients develop anti-catumaxomab antibodies, although the clinical consequences are unclear. Catumaxomab therapy is inconvenient: it lasts 10 days and requires 4 intraperitoneal infusions that last 6 hours each and require 24-hour monitoring. In practice, catumaxomab has more harms than benefits. It is better to focus on individually tailored palliative care for these terminally ill patients.

Risk Management Plans: are they a tool for improving drug safety?

PubMed

Frau, Serena; Font Pous, Maria; Luppino, Maria Rosa; Conforti, Anita

2010-08-01

In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-marketing safety issues. Of the 90 new Chemical Entities approved through a centralised procedure by the EMA during 2006 and 2007, 15 of them were selected and their safety aspects and relative RMPs analysed. All post-marketing communications released for safety reasons related to these drugs were also considered. A total of 157 safety specifications were established for the drugs assessed. Risk minimisation activities were foreseen for 5 drugs as training activities. Post-marketing safety issues emerged for 12 of them, leading to 39 type II variations in Summary of Product Characteristics (SPC). Nearly half of such variations, 19 (49%), concerned safety aspects not envisaged by the RMPs. Besides this, 9 Safety Communications were published for 6 out of 15 drugs assessed. The present study reveals several critical points on the way RMPs have been implemented. Several activities proposed by the RMPs do not appear to be adequate in dealing with the potential risks of drugs. Poor communication of risk to practitioners and to the public, and above all limited transparency for the total assessment of risk, seem to transform RMPs into a tool to reassure the public when inadequately evaluated drugs are granted premature marketing authorisation.

Truth-telling to patients' terminal illness: what makes oncology nurses act individually?

PubMed

Huang, Shu-He; Tang, Fu-In; Liu, Chang-Yi; Chen, Mei-Bih; Liang, Te-Hsin; Sheu, Shuh-Jen

2014-10-01

Nurses encounter the challenge of truth-telling to patients' terminal illness (TTPTI) in their daily care activities, particularly for nurses working in the pervasive culture of family protectiveness and medical paternalism. This study aims to investigate oncology nurses' major responses to handling this issue and to explore what factors might explain oncology nurses' various actions. A pilot quantitative study was designed to describe full-time nurses' (n = 70) truth-telling experiences at an oncology centre in Taipei. The potential influencing factors of nurses' demographic data, clinical characteristics, and truth-telling attitudes were also explored. Most nurses expressed that truth-telling was a physician's responsibility. Nevertheless, 70.6% of nurses responded that they had performed truth-telling, and 20 nurses (29.4%) reported no experience. The reasons for inaction were "Truth-telling is not my duty", "Families required me to conceal the truth", and "Truth-telling is difficult for me". Based on a stepwise regression analysis, nurses' truth-telling acts can be predicted based on less perceived difficulty of talking about "Do not resuscitate" with patients, a higher perceived authorisation from the unit, and more oncology work experience (adjusted R² = 24.1%). Oncology care experience, perceived comfort in communication with terminal patients, and unit authorisation are important factors for cultivating nurses' professional accountability in truth-telling. Nursing leaders and educators should consider reducing nursing barriers for truth-telling, improving oncology nurses' professional accountability, and facilitating better quality care environments for terminal patients. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Improving drug licensing for children and adolescents : Position paper from the More Medicines for Minors Symposion 8 June 2015 in Bonn].

PubMed

Riedel, Claudia; Lehmann, Birka; Broich, Karl; Sudhop, Thomas

2016-12-01

In Germany and throughout Europe, medicinal products for adults have been developed and evaluated systematically for decades. Medicinal products for children and adolescents, however, have only been researched for the past ten years. As a result, many medicinal products have been administered to children without systematic clinical trials, for example regarding dosage or pharmaceutical form.EU Regulation 1901/2006 aimes to close the gaps in the medical treatment of children and adolescents. In order to do so, the regulation provides for paediatric use marketing authorisations (PUMA) for previously authorised products no longer covered by intellectual property rights and also grants holders of such PUMA licenses further property rights. However, only two PUMA licenses have been applied for. Thus, the PUMA license instrument is hardly being used despite the fact that many medicinal products have a great potential for closing medical gaps for children and adolescents.In order to improve the situation regarding medicinal products for children and adolescents, this scientific symposium "More Medicines for Minors" intended to promote dialogue among the parties involved and to provide an opportunity to discuss reasons for the reluctance to apply for PUMA licenses. Speakers specialised in paediatric and adolescent medicine as well as those from licensing authorities, the Federal Joint Committee (Gemeinsamer Bundesausschuss, G‑BA), the pharmaceutical industry and the federal ministries presented problems and possible solutions from their point of view with the aim of making the PUMA license instrument more attractive.

The Relationship between Return on Profitability and Costs of Outsourcing Information Technology Technical Support

ERIC Educational Resources Information Center

Odion, Segun

2011-01-01

The purpose of this quantitative correlational research study was to examine the relationship between costs of operation and total return on profitability of outsourcing information technology technical support in a two-year period of outsourcing operations. United States of America list of Fortune 1000 companies' chief information officers…

48 CFR 915.404-2 - Information to support proposal analysis.

Code of Federal Regulations, 2010 CFR

2010-10-01

... for the auditor's review. (ii) Copies of technical analysis reports prepared by DOE technical or other... proposal analysis. 915.404-2 Section 915.404-2 Federal Acquisition Regulations System DEPARTMENT OF ENERGY... support proposal analysis. (a)(1) Field pricing assistance as discussed in FAR 15.404-2(a) is not required...

Supporting Minority-Serving Institutions in Their Program Improvement Efforts: A Responsive Technical Assistance Approach

ERIC Educational Resources Information Center

Bay, Mary; Lopez-Reyna, Norma A.; Guillory, Barbara L.

2012-01-01

To reform a special education teacher preparation program can be gratifying, difficult, complex, political, and urgently needed. The Monarch Center, a federally funded technical assistance center, was established to guide and support minority-serving institutions in their efforts to improve their teacher preparation programs. Four guidelines…

Analytical Chemistry Division. Annual progress report for period ending December 31, 1980

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lyon, W.S.

1981-05-01

This report is divided into: analytical methodology; mass and emission spectrometry; technical support; bio/organic analysis; nuclear and radiochemical analysis; quality assurance, safety, and tabulation of analyses; supplementary activities; and presentation of research results. Separate abstracts were prepared for the technical support, bio/organic analysis, and nuclear and radiochemical analysis. (DLC)

A conservation ontology and knowledge base to support delivery of technical assistance to agricultural producers in the united states

USDA-ARS?s Scientific Manuscript database

Information systems supporting the delivery of conservation technical assistance by the United States Department of Agriculture (USDA) to agricultural producers on working lands have become increasingly complex over the past 25 years. They are constrained by inconsistent coordination of domain knowl...

Promoting Teachers' Learning and Knowledge Building in a Socio-Technical System

ERIC Educational Resources Information Center

Tammets, Kairit; Pata, Kai; Laanpere, Mart

2013-01-01

The study proposes a way in which the learning and knowledge building (LKB) framework, which is consistent with the knowledge conversion phases proposed by Nonaka and Takeuchi, supports teachers' informal and self-directed workplace learning. An LKB framework in a socio-technical system was developed to support professional development in an…

Ground Water Technical Support Center (GWTSC) Annual Report FY 2012: October 2011 – September 2012

EPA Science Inventory

The Ground Water Technical Support Center (GWTSC) is part of the Ground Water and Ecosystems Restoration Division (GWERD), which is based in the Robert S. Kerr Environmental Research Center in Ada, Oklahoma. The GWERD is a research division of U.S. EPA's National Risk Management...

A consumer guide: tools to manage vegetation and fuels.

Treesearch

David L. Peterson; Louisa Evers; Rebecca A. Gravenmier; Ellen Eberhardt

2007-01-01

Current efforts to improve the scientific basis for fire management on public lands will benefit from more efficient transfer of technical information and tools that support planning, implementation, and effectiveness of vegetation and hazardous fuel treatments. The technical scope, complexity, and relevant spatial scale of analytical and decision support tools differ...

Friend or Foe? New Managerialism and Technical, Administrative and Clerical Support Staff in Australian Universities

ERIC Educational Resources Information Center

Pick, David; Teo, Stephen; Yeung, Melissa

2012-01-01

The aim of this paper is to assess and conceptualise the effects of new managerialism-related organisational reforms in three Australian public universities on technical, administrative and clerical support staff job stressors and job satisfaction. Using a mixed method approach consisting of a quantitative core component and qualitative…

7 CFR 653.4 - Availability of technical standards.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 6 2010-01-01 2010-01-01 false Availability of technical standards. 653.4 Section 653.4 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL STANDARDS § 653.4 Availability of...

Radioactive waste disposal implications of extending Part IIA of the Environmental Protection Act to cover radioactively contaminated land.

PubMed

Nancarrow, D J; White, M M

2004-03-01

A short study has been carried out of the potential radioactive waste disposal issues associated with the proposed extension of Part IIA of the Environmental Protection Act 1990 to include radioactively contaminated land, where there is no other suitable existing legislation. It was found that there is likely to be an availability problem with respect to disposal at landfills of the radioactive wastes arising from remediation. This is expected to be principally wastes of high volume and low activity (categorised as low level waste (LLW) and very low level waste (VLLW)). The availability problem results from a lack of applications by landfill operators for authorisation to accept LLW wastes for disposal. This is apparently due to perceived adverse publicity associated with the consultation process for authorisation coupled with uncertainty over future liabilities. Disposal of waste as VLLW is limited both by questions over volumes that may be acceptable and, more fundamentally, by the likely alpha activity of wastes (originating from radium and thorium operations). Authorised on-site disposal has had little attention in policy and guidance in recent years, but may have a part to play, especially if considered commercially attractive. Disposal at BNFL's near surface disposal facility for LLW at Drigg is limited to wastes for which there are no practical alternative disposal options (and preference has been given to operational type wastes). Therefore, wastes from the radioactively contaminated land (RCL) regime are not obviously attractive for disposal to Drigg. Illustrative calculations have been performed based on possible volumes and activities of RCL arisings (and assuming Drigg's future volumetric disposal capacity is 950,000 m3). These suggest that wastes arising from implementing the RCL regime, if all disposed to Drigg, would not represent a significant fraction of the volumetric capacity of Drigg, but could have a significant impact on the radiological capacity with respect to 226Ra plus 232Th. The government's decision-making programme for managing solid radioactive wastes in the UK may possibly achieve a general consensus that the use of landfill for LLW from the RCL regime has a fundamental role to play. However, this is unlikely to change the situation within the next few years. No new national facility arising from this programme is likely to be available during the first decade of the operation of a new RCL regime. Hence it appears that Drigg will need to play an important role for some years to come.

Choosing the correct forensic marker(s) in currency, document, and product protection

NASA Astrophysics Data System (ADS)

Plimmer, Jeremy J.

2006-02-01

The use of forensic markers (often known as 'tags' or taggants) as authenticity agents in currency, document and product provenance protection is gaining increased acceptance. There is now a wide choice to be made from a variety of technologies available from a number of suppliers. What criteria should be employed to aid the selection of the most appropriate technology? This paper will identify by type the range of technologies available. The use of tags and identification markers in all forms of authenticity test is highly dependent upon criteria such as the method used to deliver the marking component and the equipment needed to identify and extract the marking agent during the authorisation process. For instance, the type of marking system that can be effectively used in currency protection will require different attributes to that of a marker that identifies the authenticity of say a pharmaceutical product or the provenance of a precious stone. Such marking systems offer quality results to potential users, all of whom posses their own distinctive needs. However the correct choice will be driven by a decision making process that involves cost, speed of application, ease of recovery and low risk of compromise as well suitability for purpose. This paper will briefly identify the way forensic markers can be utilised in protecting users from various risks such as counterfeiting, dilution and refilling. This paper will also explore the technical aspects of each process with regard to characteristics and components involved in the system and then analyse the suitability of a range of available technologies to address risks on a sector by sector basis.

A Guide to Locating Technical Reports in U.S. Government Publications Collections. Metrodocs Monograph One. First Edition.

ERIC Educational Resources Information Center

Hardick, Mary

This guide is designed to provide aid and support to library staff in finding government scientific and technical reports. Following an introduction to bibliographic sources for the technical report literature, the guide outlines a general search strategy for the retrieval of technical reports and presents an overview of the following five major…

Technical Assistance From State Health Departments for Communities Engaged in Policy, Systems, and Environmental Change: The ACHIEVE Program

PubMed Central

Hefelfinger, Jenny; Patty, Alice; Ussery, Ann

2013-01-01

Introduction This study assessed the value of technical assistance provided by state health department expert advisors and by the staff of the National Association of Chronic Disease Directors (NACDD) to community groups that participated in the Action Communities for Health, Innovation, and Environmental Change (ACHIEVE) Program, a CDC-funded health promotion program. Methods We analyzed quantitative and qualitative data reported by community project coordinators to assess the nature and value of technical assistance provided by expert advisors and NACDD staff and the usefulness of ACHIEVE resources in the development and implementation of community action plans. A grounded theory approach was used to analyze and categorize phrases in text data provided by community coordinators. Open coding placed conceptual labels on text phrases. Frequency distributions of the quantitative data are described and discussed. Results The most valuable technical assistance and program support resources were those determined to be in the interpersonal domain (ie, interactions with state expert advisors, NACDD staff, and peer-to-peer support). The most valuable technical assistance events were action institutes, coaches’ meetings, webinars, and technical assistance conference calls. Conclusion This analysis suggests that ACHIEVE communities valued the management and training assistance provided by expert advisors and NACDD staff. State health department expert advisors provided technical guidance and support, including such skills or knowledge-based services as best-practice strategies, review and discussion of community assessment data, sustainability planning, and identification of possible funding opportunities. NACDD staff led development and implementation of technical assistance events. PMID:24157078

[Dual-doctor marriages].

PubMed

Gjerberg, Elisabeth

2003-08-28

Dual-doctor marriages are increasingly frequent. The question raised here is whether being married to a fellow physician has a different impact on a doctor's career and family life than having a spouse in a different profession. In 1996 a questionnaire was mailed to physicians who received their authorisation to practise medicine in Norway in the years 1980 through 1983 period; 1142 responded (67 %). They supplied data on their current employment status and data on employment history and marital background. Multivariate analysis was used in order to explore how the educational background of spouses affects a medical career. Female physicians who marry a physician marry and have families at a younger age than other female physicians. Moreover, they more often enter specialties; in some specialities they also qualify earlier than those who marry non-physicians. The same did not hold for male physicians. However, male physicians in dual-doctor marriages more frequently worked part time and they far less frequently had spouses working part time than other male doctors. The results suggest that dual-doctor couples to a higher extent share in giving care to their families, have more interests in common and are more supportive of each other's needs. Female physicians seem to benefit particularly.

RE: Request for Correction, Technical Support Document, Greenhouse Gas Emissions Reporting from the Petroleum and Natural Gas Industry

EPA Pesticide Factsheets

The Industrial Energy Consumers of America (IECA) joins the U.S. Chamber of Commerce in its request for correction of information developed by the Environmental Protection Agency (EPA) in a background technical support document titled Greenhouse Gas Emissions Reporting from the Petroleum and Natural Gas Industry

129. ARAII Administrative and technical support building (ARA606) sections showing ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

129. ARA-II Administrative and technical support building (ARA-606) sections showing roof and wall details and longitudinal section. C.A. Sundberg and Associates 866-area/ALPR-606-A-5. Date: May 1958. Ineel index code no. 070-0606-00-822-102828. - Idaho National Engineering Laboratory, Army Reactors Experimental Area, Scoville, Butte County, ID

128. ARAII Administrative and technical support building (ARA606) elevations for ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

128. ARA-II Administrative and technical support building (ARA-606) elevations for northwest, southwest, northeast, and southeast sides. C.A. Sundberg and Associates 866-area/ALPR-606-A-3. Date: May 1958. Ineel index code no. 070-0606-00-822-102826. - Idaho National Engineering Laboratory, Army Reactors Experimental Area, Scoville, Butte County, ID

78 FR 77721 - Office of Small Credit Unions (OSCUI) Grant Program Access for Credit Unions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

... any success or failure to meet objectives for use of proceeds, outcome, or impact. NCUA, in its sole... availability. The OSCUI Grant Program serves as a source of financial support, in the form of technical... provides financial support in the form of technical assistance grants to LICUs. These funds help improve...

Technical Adequacy and Acceptability of Curriculum-Based Measurement and the Measures of Academic Progress

ERIC Educational Resources Information Center

January, Stacy-Ann A.; Ardoin, Scott P.

2015-01-01

Curriculum-based measurement in reading (CBM-R) and the Measures of Academic Progress (MAP) are assessment tools widely employed for universal screening in schools. Although a large body of research supports the validity of CBM-R, limited empirical evidence exists supporting the technical adequacy of MAP or the acceptability of either measure for…

Process Hood Stand Support Steel

DOE Office of Scientific and Technical Information (OSTI.GOV)

VAN KATWIJK, C.

2000-04-03

This package is written to comply with EN-6-035-00 for upgrade dedication of commercial grade items (CGI). The SNF-5953 CGI package provides the Technical evaluation to identify the critical characteristics and the acceptance criteria associated with the safety function of the Hood Stand Support Steel. Completion of the technical and quality requirements identified in the dedication package will provide enough data to be reasonably assured that CGI Hood Stand Support Steel will perform its SC function.

Technical Support Document for Version 3.9.0 of the COMcheck Software

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bartlett, Rosemarie; Connell, Linda M.; Gowri, Krishnan

2011-09-01

COMcheck provides an optional way to demonstrate compliance with commercial and high-rise residential building energy codes. Commercial buildings include all use groups except single family and multifamily not over three stories in height. COMcheck was originally based on ANSI/ASHRAE/IES Standard 90.1-1989 (Standard 90.1-1989) requirements and is intended for use with various codes based on Standard 90.1, including the Codification of ASHRAE/IES Standard 90.1-1989 (90.1-1989 Code) (ASHRAE 1989a, 1993b) and ASHRAE/IESNA Standard 90.1-1999 (Standard 90.1-1999). This includes jurisdictions that have adopted the 90.1-1989 Code, Standard 90.1-1989, Standard 90.1-1999, or their own code based on one of these. We view Standard 90.1-1989more » and the 90.1-1989 Code as having equivalent technical content and have used both as source documents in developing COMcheck. This technical support document (TSD) is designed to explain the technical basis for the COMcheck software as originally developed based on the ANSI/ASHRAE/IES Standard 90.1-1989 (Standard 90.1-1989). Documentation for other national model codes and standards and specific state energy codes supported in COMcheck has been added to this report as appendices. These appendices are intended to provide technical documentation for features specific to the supported codes and for any changes made for state-specific codes that differ from the standard features that support compliance with the national model codes and standards. Beginning with COMcheck version 3.8.0, support for 90.1-1989, 90.1-1999, and the 1998 IECC are no longer included, but those sections remain in this document for reference purposes.« less

The National Geospatial Technical Operations Center

USGS Publications Warehouse

Craun, Kari J.; Constance, Eric W.; Donnelly, Jay; Newell, Mark R.

2009-01-01

The United States Geological Survey (USGS) National Geospatial Technical Operations Center (NGTOC) provides geospatial technical expertise in support of the National Geospatial Program in its development of The National Map, National Atlas of the United States, and implementation of key components of the National Spatial Data Infrastructure (NSDI).

Users perspectives on interactive distance technology enabling home-based motor training for stroke patients.

PubMed

Ehn, Maria; Hansson, Pär; Sjölinder, Marie; Boman, Inga-Lill; Folke, Mia; Sommerfeld, Disa; Borg, Jörgen; Palmcrantz, Susanne

2015-01-01

The aim of this work has been to develop a technical support enabling home-based motor training after stroke. The basis for the work plan has been to develop an interactive technical solution supporting three different groups of stroke patients: (1) patients with stroke discharged from hospital with support from neuro team; (2) patients with stroke whose support from neuro team will be phased out and (3) patients living with impaired motor functions long-term. The technology has been developed in close collaboration with end-users using a method earlier evaluated and described [12]. This paper describes the main functions of the developed technology. Further, results from early user-tests with end-users, performed to identify needs for improvements to be carried out during further technical development. The developed technology will be tested further in a pilot study of the safety and, usefulness of the technology when applied as a support for motor training in three different phases of the post-stroke rehabilitation process.

Food irradiation in the UK and the European Directive

NASA Astrophysics Data System (ADS)

Woolston, John

2000-03-01

Food irradiation in the UK has been authorised since the early 1990s. In principle it is possible to irradiate a wide range of foods for a variety of purposes. In practice food irradiation is virtually non-existent. The structure of food retailing in the UK, a continual stream of food safety scares and a developing public 'crisis of confidence' in the food producer/supply chain have combined to make the future for food irradiation look bleak. The new European Directive on Food Irradiation is unlikely to alter this outlook.

Should only pharmacists hold pecuniary interests in a pharmaceutical business? Attorney General (NSW) v Now.com.au Pty Ltd [2008] NSWSC 276.

PubMed

Patel, Jatine; Faunce, Thomas

2010-02-01

The New South Wales legislature's policy of authorising only registered pharmacists to hold pecuniary interests in a pharmaceutical business is a component of Australian public health policy that accords with foundational principles and virtues of health law and bioethics. The case of Attorney General (NSW) v Now.com.au Pty Ltd [2008] NSWSC 276 considered what constitutes a pecuniary interest in this context, and how this should best be deduced from facts that may be contentious.

Evaluation of Tier 5 Medical Training Initiative opportunities in dentistry.

PubMed

Wilson, M A; Burke, M

2012-03-09

This paper reviews the first two years of overseas postgraduate dental placements in the UK under the Medical Training Initiative (MTI), which is part of Tier 5 government authorised exchange. Details of the objectives of the programme, the trainees appointed, specialty areas studied and length of training are described. The methods used for assessing the training are reported. It is concluded that the objectives of the MTI have been met in dentistry and that Tier 5 provides a valuable opportunity for establishing international links in postgraduate clinical dentistry.

Quantified Trust Levels for Authentication

NASA Astrophysics Data System (ADS)

Thomas, Ivonne; Menzel, Michael; Meinel, Christoph

Service-oriented Architectures (SOAs) facilitate applications to integrate seamlessly services from collaborating business partners regardless of organizational borders. In order to secure access to these services, mechanisms for authentication and authorisation must be deployed that control the access based on identity-related information. To enable a business partners’ users to access the provided services, an identity federation is often established that enables the brokering of identity information across organisational borders. The establishment of such a federation requires complex agreements and contracts that define common policies, obligations and procedures. Generally, this includes obligations on the authentication process as well.

Positive beliefs and privacy concerns shape the future for the Personally Controlled Electronic Health Record.

PubMed

Lehnbom, E C; Douglas, H E; Makeham, M A B

2016-01-01

The uptake of the Personally Controlled Electronic Health Record (PCEHR) has been slowly building momentum in Australia. The purpose of the PCEHR is to collect clinically important information from multiple healthcare providers to provide a secure electronic record to patients and their authorised healthcare providers that will ultimately enhance the efficiency and effectiveness of healthcare delivery. Reasons for the slow uptake of the PCEHR and future directions to improve its usefulness is discussed later. © 2016 Royal Australasian College of Physicians.

Navigating through 'a labyrinth' of guidance.

PubMed

Pearson, Susan

2014-09-01

Devising a strategy to deliver safe water to thousands of outlets spread across numerous buildings is always going to be a challenge, so how do you navigate your way through a bewildering labyrinth of sometimes contradictory guidance documents? Is there, in fact, simply too much guidance? Posing this question at a recent one-day conference on waterborne infections in healthcare facilities, Paul Nolan, authorised water engineer (AE), and operations manager for PFI provider, Lend Lease, took delegates through a review of the latest guidance and regulations, as Susan Pearson reports.

EUV mask defect inspection and defect review strategies for EUV pilot line and high volume manufacturing

NASA Astrophysics Data System (ADS)

Chan, Y. David; Rastegar, Abbas; Yun, Henry; Putna, E. Steve; Wurm, Stefan

2010-04-01

Reducing mask blank and patterned mask defects is the number one challenge for extreme ultraviolet lithography. If the industry succeeds in reducing mask blank defects at the required rate of 10X every year for the next 2-3 years to meet high volume manufacturing defect requirements, new inspection and review tool capabilities will soon be needed to support this goal. This paper outlines the defect inspection and review tool technical requirements and suggests development plans to achieve pilot line readiness in 2011/12 and high volume manufacturing readiness in 2013. The technical specifications, tooling scenarios, and development plans were produced by a SEMATECH-led technical working group with broad industry participation from material suppliers, tool suppliers, mask houses, integrated device manufacturers, and consortia. The paper summarizes this technical working group's assessment of existing blank and mask inspection/review infrastructure capabilities to support pilot line introduction and outlines infrastructure development requirements and tooling strategies to support high volume manufacturing.

7 CFR 652.33 - Notice of proposed decertification.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., return receipt requested, to the technical service provider proposed for decertification a written Notice... CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE...

77 FR 41132 - Air Quality Implementation Plans; Alabama; Attainment Plan for the Alabama Portion of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-12

... modeling demonstration should include supporting technical analyses and descriptions of all relevant....5 and NO X . The attainment demonstration includes: Technical analyses that locate, identify, and... modeling analysis is a complex technical evaluation that began with selection of the modeling system. The...

76 FR 43136 - Approval and Promulgation of Air Quality Implementation Plan; Kentucky; Disapproval of Interstate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... supported by an adequate technical analysis. Second, EPA recommended the various types of information that... technical analysis, including, but not limited to, information concerning emissions in the state...: ``* * * without an adequate technical analysis EPA does not believe that states can sufficiently address the...

76 FR 14584 - Approval and Promulgation of Air Quality Implementation Plans; Montana; Attainment Plan for Libby...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

... the timeframe provided in the statute. It must also include supporting technical analyses and... emissions inventory (EI), a woodstove air pollution control calculation, and a technical analysis showing... year (2010); and (2) an attainment demonstration consisting of: (a) Technical analyses that locate...

76 FR 2853 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure State...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... technical analysis submitted for parallel-processing by DNREC on December 9, 2010, to address significant... technical analysis submitted by DNREC for parallel-processing on December 9, 2010, to satisfy the... consists of a technical analysis that provides detailed support for Delaware's position that it has...

Progress in Scientific and Technical Communications, 1968 Annual Report.

ERIC Educational Resources Information Center

Federal Council for Science and Technology, Washington, DC. Committee on Scientific and Technical Information.

This sixth annual report describes progress achieved by the Federal Government in improving the communication of scientific and technical information to support and enhance national science and technology. Included in the report are details regarding the scientific and technical activities of individual Federal Agencies, such as the Atomic Energy…

75 FR 9193 - Office of Special Education and Rehabilitative Services; Overview Information; Assistive...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

... Information; Assistive Technology Act of 1998, as Amended--National Activities--State Training and Technical... requirement to support training and technical assistance to the entities funded under the AT Act to improve... applications that meet this priority. This priority is: State Training and Technical Assistance for Assistive...

A Decision Support Tool to Evaluate Sources and Sinks of Nitrogen within a Watershed Framework

EPA Science Inventory

Human transformation of the nitrogen (N) cycle is causing a number of environmental and human health problems. Federal, state and local authorities focusing on management of N loadings face both technical and non-technical challenges. One technical issue is that we need a bette...

48 CFR 252.227-7015 - Technical data-Commercial items.

Code of Federal Regulations, 2013 CFR

2013-10-01

... support contractor means a contractor under a contract, the primary purpose of which is to furnish...) Form, fit, and function data means technical data that describes the required overall physical... another party; (ii) Are form, fit, and function data; (iii) Are a correction or change to technical data...

48 CFR 252.227-7015 - Technical data-Commercial items.

Code of Federal Regulations, 2012 CFR

2012-10-01

... support contractor means a contractor under a contract, the primary purpose of which is to furnish...) Form, fit, and function data means technical data that describes the required overall physical... another party; (ii) Are form, fit, and function data; (iii) Are a correction or change to technical data...

48 CFR 252.227-7015 - Technical data-Commercial items.

Code of Federal Regulations, 2011 CFR

2011-10-01

... support contractor means a contractor under a contract, the primary purpose of which is to furnish...) Form, fit, and function data means technical data that describes the required overall physical... another party; (ii) Are form, fit, and function data; (iii) Are a correction or change to technical data...

Technical Support Document for Version 3.4.0 of the COMcheck Software

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bartlett, Rosemarie; Connell, Linda M.; Gowri, Krishnan

2007-09-14

COMcheck provides an optional way to demonstrate compliance with commercial and high-rise residential building energy codes. Commercial buildings include all use groups except single family and multifamily not over three stories in height. COMcheck was originally based on ANSI/ASHRAE/IES Standard 90.1-1989 (Standard 90.1-1989) requirements and is intended for use with various codes based on Standard 90.1, including the Codification of ASHRAE/IES Standard 90.1-1989 (90.1-1989 Code) (ASHRAE 1989a, 1993b) and ASHRAE/IESNA Standard 90.1-1999 (Standard 90.1-1999). This includes jurisdictions that have adopted the 90.1-1989 Code, Standard 90.1-1989, Standard 90.1-1999, or their own code based on one of these. We view Standard 90.1-1989more » and the 90.1-1989 Code as having equivalent technical content and have used both as source documents in developing COMcheck. This technical support document (TSD) is designed to explain the technical basis for the COMcheck software as originally developed based on the ANSI/ASHRAE/IES Standard 90.1-1989 (Standard 90.1-1989). Documentation for other national model codes and standards and specific state energy codes supported in COMcheck has been added to this report as appendices. These appendices are intended to provide technical documentation for features specific to the supported codes and for any changes made for state-specific codes that differ from the standard features that support compliance with the national model codes and standards.« less

Distance Education Programs in Texas Community & Technical Colleges: Assessing Student Support Services in a Virtual Environment.

ERIC Educational Resources Information Center

Luedtke, Cherry Beth

This project evaluates the status of distance learning at 54 public, two-year community, and technical colleges in Texas. Data was collected from the Web sites of each of the institutions. The Web site data indicted that 44 of the colleges refer specifically to distance education courses offered. To assess what student support services are…

127. ARAII Administrative and technical support building (ARA606) ground floor ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

127. ARA-II Administrative and technical support building (ARA-606) ground floor plan. Indicates use of rooms for classrooms, offices, and lunch room. C.A. Sundberg and Associates 866-area-ALPR-606-A-2. Date: June 1958. Ineel index code no. 070-0606-00-822-102825. - Idaho National Engineering Laboratory, Army Reactors Experimental Area, Scoville, Butte County, ID

New Jersey Technical Assistance Project (N.J. TAP): "Educational Resources and Support Services on Behalf of Children with Multiple Sensory Impairment." Final Report.

ERIC Educational Resources Information Center

New Jersey State Dept. of Education, Trenton.

This final report describes activities and accomplishments of the New Jersey Technical Assistance Project, a project to improve educational resources and support services for students with multiple sensory impairment (deaf-blindness). Activities and accomplishments are presented in a tabular format for each project goal and objective. The project…

GPHS-RTGs in support of the Cassini RTG Program

NASA Astrophysics Data System (ADS)

1995-04-01

The technical progress achieved during the period 26 Sep. 1994 - 2 Apr. 1995 on Contract DE-AC03-91SF-18852 Radioisotope Thermoelectric Generators and Ancillary Activities is described herein. Monthly technical activity for the period 27 Feb. - 2 Apr. 1995 is included in this progress report. The report addresses tasks, including: spacecraft integration and liaison; engineering support; safety; qualified unicouple production; ETG fabrication, assembly, and test; ground support equipment; RTG shipping and launch support; designs, reviews, and mission applications; project management, quality assurance, reliability, contract changes, CAGO acquisition (operating funds), and CAGO maintenance and repair; and CAGO acquisition (capital funds).

GEO-6 project for Galileo data scientific utilization

NASA Astrophysics Data System (ADS)

Buresova, Dalia; Lastovicka, Jan; Boska, Josef; Sauli, Petra; Kouba, Daniel; Mosna, Zbysek

The future GNSS Galileo system offer a number of benefits (e.g. availability of better accuracy positioning, new frequencies bands allowing the implementation of specific techniques, provable time-stamp and location data using SIS authorisation, integrity, better support ad-hoc algorithms for data analysis and other service guarantee for liability and regulated applications) are widely spread among different disciplines. Also applications which are less interesting from the commercial and market point of view could successfully contribute to the numerous social benefits and support the innovation in the international research. The aim of the GEO-6 project "Scientific research Using GNSS" is to propose and broaden scientific utilization of future GNSS Galileo system data in research. It is a joint project of seven institutions from six countries led by the Atos Origin Company from Spain. The core of the project consists from six projects in five priority areas: PA-1 Remote sensing of the ocean using GNSS reflections, PA-2a Investigating GNSS ionospheric data assimilation, PA-2b 3-D gravity wave detection and determination (both PA-2a and PA-2b are ionospheric topics), PA-3 Demonstration of capability for operational forecasting of atmospheric delays, PA-4 GNSS seismometer, PA-5 Spacecraft formation flying using global navigation satellite systems. Institute of Atmospheric Physics, Prague, Czech Republic is responsible for the project PA-2b, where we developed and tested (to the extent allowed by available data) an algorithm and computer code for the 3-D detection of gravity waves and determination of their characteristics. The main drivers of the GEO-6 project are: high levels of accuracy even with the support of local elements, sharing of solutions and results for the worldwide scientific community. The paper will present basic description of the project with more details concerning Czech participation in it.

The effects of customers' mobile experience and technical support on the intention to use mobile banking.

PubMed

Chung, Namho; Kwon, Soon Jae

2009-10-01

While mobile banking has become an integral part of banking activities, it has also caused systems-related stress and consequent distrust among mobile banking users. This study looks into the phenomenon of technology adoption for mobile banking users and identifies potential factors that nurture positive intentions toward mobile banking usage. It examines the effects of a customer's mobile experience and technical support on mobile banking acceptance and explains how some variables affect this intention. After a literature review, the method of empirical analysis using a structured questionnaire is developed. Hierarchical Moderated Regression Analyses (HMRA) is used to examine the model. We find that mobile experience and technical support tend to strengthen the relationship between technological characteristics and a customer's intention to use the mobile technology.

77 FR 15995 - Notice of Request for Extension of a Currently Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... information collection in support of the program for Self-Help Technical Assistance Grants (7 CFR part 1944-I...-0783, Telephone (202) 720-1489. SUPPLEMENTARY INFORMATION: Title: 7 CFR 1944-I, Self-Help Technical... programs of technical and supervisory assistance for self-help housing loan program, as authorized under...

Scientific and Technical Information in Canada, Part II, Chapter 1: Government Departments and Agencies.

ERIC Educational Resources Information Center

Science Council of Canada, Ottawa (Ontario).

Canada's major scientific and technical information resources are supported largely by the Federal Government. They consist of libraries, data files, specialized information centers, and field services. The Canadian Government has no overall policy concerning the handling of scientific and technical information. The need for a national information…

78 FR 29314 - Approval and Promulgation of State Implementation Plans; State of Utah; Interstate Transport of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

...) SIP submissions an adequate technical analysis to support their conclusions regarding interstate... acceptable modeling technical analyses are available, but EPA does not believe that modeling is required if... regional scale technical analysis, and Utah will point to that analysis in order to conclude that there are...

20 CFR 411.180 - What is timely progress toward self-supporting employment?

Code of Federal Regulations, 2010 CFR

2010-04-01

... certificate or vocational or technical training that will enhance your ability to return to work. In addition...-secondary education requirement or vocational or technical training requirement in the applicable progress... this 12-month period; or (iv) You must have been enrolled in a vocational or technical training program...

Transferring Codified Knowledge: Socio-Technical versus Top-Down Approaches

ERIC Educational Resources Information Center

Guzman, Gustavo; Trivelato, Luiz F.

2008-01-01

Purpose: This paper aims to analyse and evaluate the transfer process of codified knowledge (CK) performed under two different approaches: the "socio-technical" and the "top-down". It is argued that the socio-technical approach supports the transfer of CK better than the top-down approach. Design/methodology/approach: Case study methodology was…

How to Improve the Design and Delivery of High-Quality Technical Assistance. Newsletter

ERIC Educational Resources Information Center

Center for Comprehensive School Reform and Improvement, 2005

2005-01-01

Educators often use the term technical assistance to define services delivered or received in the pursuit of school- and district-improvement initiatives. More specifically, technical assistance can be defined as any assistance that identifies, selects, or designs research-based solutions and practices to support school improvement (Mattson &…

78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

...] Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and... availability of a final guidance document entitled ``Technical Considerations for Pen, Jet, and Related... developing information to support a marketing application for a pen, jet, or related injector device intended...

SolSmart Launches to Support Local Governments | State, Local, and Tribal

Science.gov Websites

Local Governments May 04, 2016 by Erin Nobler As a member of the Solar Technical Assistance Team (STAT ) network, the National Renewable Energy Laboratory (NREL) provides direct technical assistance to state and no-cost technical assistance. Business processes or administrative costs, the so-called "soft

The Technical Baccalaureate: Providing Excellence in Vocational Education?

ERIC Educational Resources Information Center

Acquah, Daniel K.; Malpass, Debra

2017-01-01

Proposals for a technical baccalaureate have received cross-party support in England. The technical baccalaureate is intended to deliver the necessary training to enable young people to fill the UK's skills gap in intermediate-level occupations in STEM and other sectors. This paper explores how to design and implement a high-quality technical…

Space Shuttle Technical Conference, Part 2

NASA Technical Reports Server (NTRS)

Chaffee, Norman (Compiler)

1985-01-01

The retrospective presentation provides technical disciplinary focus in the following technical areas: (1) integrated avionics; (2) guidance, navigation, and control; (3) aerodynamics; (4) structures; (5) life support, environmental control, and crew station; (6) ground operations; (7) propulsion and power; (8) communications and tracking; (9) mechanics and mechanical systems; and (10) thermal and contamination environments and protection systems.

An Analysis of Gateway Technical College Instructors' Opinions on Secondary and Postsecondary Program Alignment

ERIC Educational Resources Information Center

Albrecht, Bryan D.

2011-01-01

The purpose of this study was to determine what opinions Gateway Technical College instructors had toward secondary and postsecondary program alignment. Student transition is critical to supporting the mission and vision of Gateway Technical College. The impetus for this study was twofold. First, the quality improvement process established at…

TADS and Technical Assistance: Readings on System Design, Needs Assessment, Consultation, and Evaluation.

ERIC Educational Resources Information Center

Trohanis, Pascal L., Ed.

The document reviews the technical assistance process used by TADS (Technical Assistance Development System), a project to provide support to HCEEP (Handicapped Children's Early Education Program) demonstration projects serving young handicapped children and their families. Chapter 1, by P. Trohanis, focuses on a number of questions that people…

[Job satisfaction in an Italian university: difference between academic and technical-administrative staff].

PubMed

Ghislieri, Chiara; Colombo, Lara; Molino, Monica; Zito, Margherita; Curzi, Ylenia; Fabbri, Tommaso

2014-01-01

The changes in the academic world led to an increase in job demands and a decrease in the available job resources. In recent years, the positive image of work in academia has gradually blurred. The present study, within the theoretical framework of the job demands-resources model, aimed to analyse the relationship between some job demands (workload, work-family conflict and emotional dissonance) and some job resources (autonomy, supervisors' support and co-workers' support) and job satisfaction in a medium-sized Italian University, by observing the differences between the academic staff (professors and researchers) and the technical-administrative staff The research was conducted by administering a self-report questionnaire which allowed to detect job satisfaction and the mentioned variables. Respondents were 477 (177 from academic staff and 300 from technical-administrative staff). The analysis of variance (independent samples t-test) showed significant differences in variables of interest between academic staff and technical-administrative staff. Multiple regression pointed out that job autonomy is the main determinant of job satisfaction in the academic staff sample, whereas supervisor support is the main determinant of job satisfaction in the technical-administrative staff sample. This research represents one of the first Italian studies on these topics in the academic context and highlights the importance of further in-depth examinations of specific job dynamics for both teaching and technical-administrative staff. Among practical implications, the importance of keeping high levels of job autonomy for academic staff and of fostering an effective leadership development for technical-administrative staff emerged.

Institutional authorisation and accreditation of Transfusion Services and Blood Donation Sites: results of a national survey

PubMed Central

Liumbruno, Giancarlo Maria; Panetta, Valentina; Bonini, Rosaria; Chianese, Rosa; Fiorin, Francesco; Lupi, Maria Antonietta; Tomasini, Ivana; Grazzini, Giuliano

2011-01-01

Introduction The aim of the survey described in this article was to determine decisional and strategic factors useful for redefining minimum structural, technological and organisational requisites for transfusion structures, as well as for the production of guidelines for accreditation of transfusion structures by the National Blood Centre. Materials and methods A structured questionnaire containing 65 questions was sent to all Transfusion Services in Italy. The questions covered: management of the quality system, accreditation, conformity with professional standards, structural and technological requisites, as well as potential to supply transfusion medicine-related health care services. All the questionnaires returned underwent statistical analysis. Results Replies were received from 64.7% of the Transfusion Services. Thirty-nine percent of these had an ISO 9001 certificate, with marked differences according to geographical location; location-related differences were also present for responses to other questions and were confirmed by multivariate statistical analysis. Over half of the Transfusion Services (53.6%) had blood donation sites run by donor associations. The statistical analysis revealed only one statistically significant difference between these donation sites: those connected to certified Transfusion Services were more likely themselves to have ISO 9001 certification than those connected to services who did not have such certification. Conclusions The data collected in this survey are representative of the Italian national transfusion system. A re-definition of the authorisation and accreditation requisites for transfusion activities must take into account European and national legislation when determining these requisites in order to facilitate their effective applicability, promote their efficient fulfilment and enhance the development of homogeneous and transparent quality systems. PMID:21839026

[A standardised German translation of the STAndards for Reporting of Diagnostic accuracy studies (STARD statement)*: Methodological aspects].

PubMed

Breuer, Jan-Philipp; Seeling, Matthes; Barz, Michael; Baldini, Timo; Scholtz, Kathrin; Spies, Claudia

2012-01-01

In order to be comprehensible and comparable scientific data should be reported according to a certain standard. One example is the 'STAndards for Reporting of Diagnostic Accuracy (STARD) Statement', a 25-item checklist for the appropriate conduct and reporting of diagnostic studies. Usually such scientific standards are published in English. The International Society for Pharmacoeconomics and Outcome Research (ISPOR) has developed guidelines for the translation and cultural adaptation of written medical instruments. The aim was to apply these ISPOR criteria to the German translation of the STARD Statement in order to allow for authorisation to be conferred by the original authors. In cooperation with the original authors the STARD statement was translated according to the ISPOR steps: (1) Preparation, (2) Forward Translation, (3) Reconciliation, (4) Back Translation, (5) Back Translation Review, (6) Harmonisation, (7) Cognitive Debriefing, which evaluated comprehensiveness and linguistic style with marks from 1 (very good) to 6 (insufficient), and (8) Review of Cognitive Debriefing Results and Finalisation. Die ISPOR criteria applied reasonably to the translation process, which required the work input and energy of four scientists and one professional translator and 177 accumulated working hours. The cognitive debriefing resulted in average grades 1.62±0.33 and 1.72±0.39 for comprehensiveness and linguistic style, respectively. Finally, the German STARD version was authorised by the original authors. Die ISPOR guidelines seem to be a suitable means to facilitate the structured adaptation of defined criteria for the reporting of studies, such as the STARD statement, to other languages. Copyright © 2012. Published by Elsevier GmbH.

Bt maize and integrated pest management--a European perspective.

PubMed

Meissle, Michael; Romeis, Jörg; Bigler, Franz

2011-09-01

The European corn borer (Ostrinia nubilalis), the Mediterranean corn borer (Sesamia nonagrioides) and the western corn rootworm (Diabrotica virgifera virgifera) are the main arthropod pests in European maize production. Practised pest control includes chemical control, biological control and cultural control such as ploughing and crop rotation. A pest control option that is available since 1996 is maize varieties that are genetically engineered (GE) to produce insecticidal compounds. GE maize varieties available today express one or several genes from Bacillus thuringiensis (Bt) that target corn borers or corn rootworms. Incentives to growing Bt maize are simplified farm operations, high pest control efficiency, improved grain quality and ecological benefits. Limitations include the risk of resistance evolution in target pest populations, risk of secondary pest outbreaks and increased administration to comply with licence agreements. Growers willing to plant Bt maize in the European Union (EU) often face the problem that authorisation is denied. Only one Bt maize transformation event (MON810) is currently authorised for commercial cultivation, and some national authorities have banned cultivation. Spain is the only EU member state where Bt maize adoption levels are currently delivering farm income gains near full potential levels. In an integrated pest management (IPM) context, Bt maize can be regarded as a preventive (host plant resistance) or a responsive pest control measure. In any case, Bt maize is a highly specific tool that efficiently controls the main pests and allows combination with other preventive or responsive measures to solve other agricultural problems including those with secondary pests. Copyright © 2011 Society of Chemical Industry.

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

PubMed Central

Carroll, Robert; Ramagopalan, Sreeram V.; Cid-Ruzafa, Javier; Lambrelli, Dimitra; McDonald, Laura

2017-01-01

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18 th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that PAS design varies according to study objectives and therapeutic area. PMID:29188016

[European Marketing Authorisation: a long process. Experiences of small biotech companies with the ATMP regulation].

PubMed

Buljovčić, Z

2011-07-01

On 30 December 2008, the Regulation (EC) 1394/2007 on advanced therapy medicinal products (ATMPs) entered into force. Herewith the first EU-wide regulatory framework for ATMPs was established. It requires a central marketing authorisation application to the EMA (European Medicinal Agency). This new framework especially changes the code of regulatory practice for tissue engineered products (TEPs), as no registration procedure had been previously required for autologous TEPs. This also meant that no clinical proof of efficacy achieved by a pivotal clinical trial was necessary. Difficulties and their background as well as the vast requirements for product development that have to be addressed by small companies within a very short time frame are presented. Hereby, it is obvious that regulatory experience which is required to identify and implement the resulting implications was not in place yet and still had to be established. The lack of regulatory experience also resulted in difficulties with scientific advice preparation, expectations toward regulatory agencies, consultants, and transformation of regulatory requirements. Addressing the regulatory requirements within the transition period is even more difficult for entrepreneurs with products which are assigned for indications resulting in complex challenges to the trial design. Due to the enormous time pressure to generate data and due to the implied financial pressure, different adaptation strategies are evolving. In Germany the "hospital exemption" according to §4b AMG (German Medicinal Products Law) is of major importance. A reorientation toward acellular products and a slow down in development of new ATMP products is expected.

Engineering, technical, and management support services

NASA Technical Reports Server (NTRS)

1994-01-01

This report summarizes by task the engineering, technical, and management support services provided by Vitro Corporation to NASA Headquarters Office of Safety, Reliability, Maintainability, and Quality Assurance (now called Office of Safety and Mission Assurance (OSMA)) (Code Q) under Contract Number NASW-4311 from the period February 10, 1994. Each task summary includes significant Vitro accomplishments, conclusions, and recommendations for future efforts in each of the divisions within OSMA.

Technical College Instructors' Perceptions of the Impact of Online Readiness and of Student Support Services on Student Success in Online Courses

ERIC Educational Resources Information Center

Dowd, Nathan

2012-01-01

The purpose of this study is to determine how Wisconsin Technical College (WTCS) administrators and online instructors perceive the impact of online learner readiness and student support services to be on student success in online courses. The study used a modified three-round Delphi technique to determine to collect data. The results indicated…

Review of Final Year MSP Evaluations, Performance Period 2007. Analytic and Technical Support for Mathematics and Science Partnerships

ERIC Educational Resources Information Center

Bobronnikov, Ellen; Rhodes, Hilary; Bradley, Cay

2010-01-01

This final report culminates the evaluation and technical assistance provided for the U.S. Department of Education's Mathematics and Science Partnership (MSP) Program and its projects since 2005. As part of this support, Abt Associates looked across the portfolio of projects funded by the MSP program to draw lessons on best practices. This…

Technical Assistance and Changes in Nutrition and Physical Activity Practices in the National Early Care and Education Learning Collaboratives Project, 2015-2016.

PubMed

Chiappone, Alethea; Smith, Teresa M; Estabrooks, Paul A; Rasmussen, Cristy Geno; Blaser, Casey; Yaroch, Amy L

2018-04-26

The National Early Care and Education Learning Collaboratives Project (ECELC) aims to improve best practices in early care and education (ECE) programs in topic areas of the Nutrition and Physical Activity Self-Assessment in Child Care (NAP SACC). Technical assistance is a component of the ECELC, yet its effect on outcomes is unclear. Beyond dose and duration of technical assistance, limited research exists on characteristics of technical assistance that contribute to outcomes. The objective of this study was to identify and describe technical assistance characteristics and explore associations with NAP SACC outcomes. We collected data from 10 collaboratives comprising 84 ECE programs in 2 states in 2015-2016. The objective of technical assistance was to support programs in improving best practices. Technical assistance was provided to programs via on-site, telephone, or email and was tailored to program needs. We used a mixed-methods design to examine associations between technical assistance and NAP SACC outcomes. We used multiple regression analysis to assess quantitative data and qualitative comparative analysis to determine necessary and sufficient technical assistance conditions supporting NAP SACC outcomes. We also conducted a document review to describe technical assistance that referred conditions identified by the qualitative comparative analysis. Regression analyses detected an inverse relationship between changes in NAP SACC scores and hours of technical assistance. No clear pattern emerged in the qualitative comparative analysis, leaving no necessary and sufficient conditions. However, the qualitative comparative analysis identified feedback as a potentially important component of technical assistance, whereas resource sharing and frequent email were characteristics that seemed to reduce the likelihood of improved outcomes. Email and resource sharing were considered primarily general information rather than tailored technical assistance. Technical assistance may be used in programs and made adaptable to program needs. The inclusion and evaluation of technical assistance, especially tailored approaches, is warranted for environmental interventions, including ECE settings.

Chlordane (Technical)

Integrated Risk Information System (IRIS)

TOXICOLOGICAL REVIEW of CHLORDANE ( TECHNICAL ) ( CAS No . 12789 - 03 - 6 ) In Support of Summary Information on the Integrated Risk Information System ( IRIS ) December 1997 U.S . Environmental Protection Agency Washington , DC TABLE OF CONTENTS Authors and Reviewers . . . . . . . . . . . . .

Implementing assessments of robot-assisted technical skill in urological education: a systematic review and synthesis of the validity evidence.

PubMed

Goldenberg, Mitchell G; Lee, Jason Y; Kwong, Jethro C C; Grantcharov, Teodor P; Costello, Anthony

2018-03-31

To systematically review and synthesise the validity evidence supporting intraoperative and simulation-based assessments of technical skill in urological robot-assisted surgery (RAS), and make evidence-based recommendations for the implementation of these assessments in urological training. A literature search of the Medline, PsycINFO and Embase databases was performed. Articles using technical skill and simulation-based assessments in RAS were abstracted. Only studies involving urology trainees or faculty were included in the final analysis. Multiple tools for the assessment of technical robotic skill have been published, with mixed sources of validity evidence to support their use. These evaluations have been used in both the ex vivo and in vivo settings. Performance evaluations range from global rating scales to psychometrics, and assessments are carried out through automation, expert analysts, and crowdsourcing. There have been rapid expansions in approaches to RAS technical skills assessment, both in simulated and clinical settings. Alternative approaches to assessment in RAS, such as crowdsourcing and psychometrics, remain under investigation. Evidence to support the use of these metrics in high-stakes decisions is likely insufficient at present. © 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.

Ipilimumab for Previously Untreated Unresectable Malignant Melanoma: A Critique of the Evidence.

PubMed

Giannopoulou, Christina; Sideris, Eleftherios; Wade, Ros; Moe-Byrne, Thirimon; Eastwood, Alison; McKenna, Claire

2015-12-01

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of ipilimumab (Bristol-Myers Squibb Pharmaceuticals Limited) to submit clinical and cost-effectiveness evidence for previously untreated advanced (unresectable or metastatic) melanoma as part of the Institute's Single Technology Appraisal process. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This article presents a summary of the manufacturer's submission of ipilimumab, the ERG review and the resulting NICE guidance TA319, issued in July 2014. Ipilimumab at a recommended dose of 3 mg/kg monotherapy was previously granted marketing authorisation by the European Medicines Agency in adult patients who had received prior therapy and was recommended by NICE in guidance TA268. In October 2013, the EMA approved the extension of this indication to previously untreated advanced melanoma patients. NICE decisions are bound by the marketing authorisation; therefore, the decision problem faced by the NICE Appraisal Committee was whether ipilimumab at a recommended dose of 3 mg/kg monotherapy was effective and cost effective compared with first-line standard of care involving dacarbazine (DTIC) and vemurafenib (for BRAF V600 mutation-positive patients). The CA184-024 trial was the primary source of clinical evidence for ipilimumab. However, this was based on a dose of 10 mg/kg with concomitant DTIC. The results over a 5-year period indicated that ipilimumab 10 mg/kg plus DTIC demonstrated a significant increase in median overall survival (OS) of 2.1 months compared with DTIC plus placebo (11.2 vs. 9.1 months). The BRIM-3 trial, which was an open-label randomised controlled trial (RCT) in BRAF V600 mutation-positive patients, was the primary source of evidence for an indirect comparison with vemurafenib. The results showed that vemurafenib increased median OS by 3.6 months compared with DTIC (13.2 vs. 9.6 months). The economic evaluation compared the costs and outcomes of ipilimumab by assuming that the 3 mg/kg dosing regimen was clinically equivalent in efficacy to an ipilimumab 10 mg/kg dosing regimen plus DTIC and by using a treatment sequencing approach that incorporated second-line active therapy and third-line best supportive care (BSC). In the first appraisal meeting, the committee recommended ipilimumab only in the context of research as part of a clinical study. This was primarily based on the lack of robust evidence to support the assumption of clinical equivalence between dosages and the absence of evidence available to inform the sequential use of treatments. Following the consultation, the manufacturer submitted additional analyses and evidence to support the cost effectiveness of ipilimumab at first line. The manufacturer's response was based on concerns relating to uncertainty surrounding the relative efficacy of ipilimumab 3 mg/kg monotherapy compared with DTIC and vemurafenib, comparability of the patient populations at first and second line, and the effects of concomitant DTIC. These additional analyses indicated that the incremental cost-effectiveness ratio (ICER) was £ 47,900 per quality-adjusted life-year (QALY) gained for ipilimumab compared with DTIC and £ 28,600 per QALY gained for ipilimumab compared with vemurafenib. Following consideration of the additional evidence and the responses from a large number of consultees and commentators, the committee recommended ipilimumab as an option for adults with previously untreated advanced melanoma.

78 FR 15664 - Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Interstate Transport...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-12

... technical analysis supporting New Mexico's conclusion as recommended by EPA's guidance memorandum that... modeling technical analyses are available, but EPA does not believe that modeling is necessarily required...)(2)(D)(i)(I) for the 2006 PM 2.5 NAAQS in several ways. It takes into account the technical analysis...

Keep Your Small Network Sailing Safely in Dangerous Waters

ERIC Educational Resources Information Center

Semmelroth, Jim

2006-01-01

Asmall library's essential technical problem is that it has to chart a course through the technology shoals without a navigator on board. Small libraries in small towns often have a very low level of technical skill on staff. Furthermore, obtaining skilled technical support can frequently be pretty expensive. Even when one is available, a clever…

An Intensive Onsite Technical Assistance Model to Promote Inclusive Educational Practices for Students with Disabilities in Middle School and High School

ERIC Educational Resources Information Center

Clark, Nitasha M.; Cushing, Lisa S.; Kennedy, Craig H.

2004-01-01

The authors examined the effects of an intensive onsite technical assistance (IOTA) model on the inclusive practices of special educators. Three special educators received technical assistance that included performance assessments, workshops on inclusive practices, and intensive onsite follow-up support. Inclusive practices were measured using…

Technical guidelines for environmental dredging of contaminated sediments

DOT National Transportation Integrated Search

2008-09-01

This report provides technical guidelines for evaluating : environmental dredging as a sediment remedy component. This document : supports the Contaminated Sediment Remediation Guidance for : Hazardous Waste Sites, released by the U.S. Environmental ...

78 FR 49749 - Trailblazer Pipeline Company LLC; Notice of Technical Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-15

... technical, engineering, and operational support for its proposed gas quality specifications. Consistent with... Rehabilitation Act of 1973. For accessibility accommodations please send an email to [email protected] or...

The New Jersey Police Technical Assistance Program

DOT National Transportation Integrated Search

2007-03-01

The Police Technical Assistance Program (PTAP), a federal model, was adopted to support the New Jersey Department of Transportation (NJDOT)s safety mission. Several activities were included in this initiative: conducting assessments, providing tec...

Development of Technical Basis for Burnup Credit Regulatory Guidance in the United States

DOE Office of Scientific and Technical Information (OSTI.GOV)

Parks, Cecil V; Wagner, John C; Mueller, Don

2011-01-01

In the United States (U.S.) there has been and continues to be considerable interest in the increased use of burnup credit as part of the safety basis for SNF systems and this interest has motivated numerous technical studies related to the application of burnup credit for maintaining subcriticality. Responding to industry requests and needs, the U.S. Nuclear Regulatory Commission initiated a burnup credit research program, with support from the Oak Ridge National Laboratory, to develop regulatory guidance and the supporting technical basis for allowing and expanding the use of burnup credit in pressurized-water reactor SNF storage and transport applications. Themore » objective of this paper is to summarize the work and significant accomplishments, with references to the technical reports and publications for complete details.« less

Geographic patterns of at-risk species: A technical document supporting the USDA Forest Service Interim Update of the 2000 RPA Assessment

Treesearch

Curtis H. Flather; Michael S. Knowles; Jason McNees

2008-01-01

This technical document supports the Forest Service's requirement to assess the status of renewable natural resources as mandated by the Forest and Rangeland Renewable Resources Planning Act of 1974. It updates past reports on the trends and geographic patterns of species formally listed as threatened or endangered under the Endangered Species Act of 1973. We...

PNNL Supports Hanford Waste Treatment

ScienceCinema

None

2018-04-16

For more than 40 years, technical assistance from PNNL has supported the operations and processing of Hanford tank waste. Our expertise in tank waste chemistry, fluid dynamics and scaling, waste forms, and safety bases has helped to shape the site’s waste treatment baseline and solve operational challenges. The historical knowledge and unique scientific and technical expertise at PNNL are essential to the success of the Hanford mission.

Technical Support Document: 50% Energy Savings Design Technology Packages for Highway Lodging Buildings

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jiang, Wei; Gowri, Krishnan; Lane, Michael D.

2009-09-28

This Technical Support Document (TSD) describes the process, methodology and assumptions for development of the 50% Energy Savings Design Technology Packages for Highway Lodging Buildings, a design guidance document intended to provide recommendations for achieving 50% energy savings in highway lodging properties over the energy-efficiency levels contained in ANSI/ASHRAE/IESNA Standard 90.1-2004, Energy Standard for Buildings Except Low-Rise Residential Buildings.

A review of clinical and technical considerations for fixed and removable implant prostheses in the edentulous mandible.

PubMed

Zitzmann, Nicola Ursula; Marinello, Carlo Paolo

2002-01-01

The aim of the present article is to review some of the technical treatment options for implant prostheses restoring the edentulous mandible, mainly based on the Brånemark system. Clinical and technical aspects are discussed for the three established concepts: (1) implant-supported fixed prosthesis, (2) removable implant-supported overdenture, and (3) combined implant-retained and soft tissue-supported overdenture prosthesis. The framework of an implant-supported fixed screw-retained prosthesis can be processed in gold, Co-Cr alloy, or titanium with casting, laser-welding, or milling techniques. To improve the stability and retention of a conventional complete denture, one to four implants are indicated, and unsplinted (single attachments) or splinted designs (bar systems) can be applied. The design of the overdenture prosthesis must be carefully planned according to the requirements to ensure adequate stability and optimal form, contour, and esthetics, and the patient's best comfort. A large variety of different treatment modalities exist for both the fixed and removable mandibular implant prosthesis. Clinical and technical aspects should be considered at the beginning of the treatment to: (1) select the optimal implant position, (2) establish an adequate number of functional units, (3) select the appropriate retainers, and (4) apply the best technique for framework processing and veneering.

[Marketing of medicinal products in the European Community. The Mutual Recognition and Decentralised Procedures].

PubMed

Bachmann, Peter

2008-07-01

The Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP), which were first established in late 2005, can be regarded as the backbone for marketing authorisation of medicinal products in the European Community (EC) and the European Economic Area (EEA). Both procedures are compared and advantages and disadvantages are discussed. However, the focus is more related to current developments than the detailed comparison of both procedures. The role of the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMD(h)) and the decision making process in relation to the MRP and DCP is also discussed.

[Major milestones for European pharmaceutical policy].

PubMed

Sauer, Fernand

2014-01-01

Under the 1985 White Paper on the completion of the single market, several pharmaceutical harmonisation measures were unanimously adopted, in favor of biotech products and on pricing transparency, legal status of prescription, wholesale distribution and advertising. The European pharmaceutical harmonisation was extended to Norway and Iceland, to new accession member states and through major international conferences with the US and Japan (ICH). Starting in 1995, the European medicines agency has produced an efficient marketing authorisation system for new human and veterinary medicines. The system was extended to pediatric medicines and advanced therapies. The monitoring of drug adverse effects (pharmacovigilance) has been gradually strengthened.

The Small- and Medium-sized Enterprises Office (SME Office) at the European Medicines Agency.

PubMed

Carr, M

2010-01-01

On 15 December 2005, the European Medicines Agency (EMEA) launched an "SME Office" to provide financial and administrative assistance to micro-, small- and medium-sized enterprises (SMEs), with the aim of promoting innovation and the development of new human and veterinary medicinal products by SMEs. According to current EU definition of an SME, companies with fewer than 250 employees, and an annual turnover of not more than 50 million euro or an annual balance sheet total of not more than 43 million euro, are eligible for assistance from the SME Office. Incentives available from the EMEA for SMEs, include: Administrative and procedural assistance from SME Office within the Agency; Fee reductions (90%) for scientific advice and inspections; Fee exemptions for certain administrative services (excluding parallel distribution); Deferral of the fee payable for an application for marketing authorisation or related inspection until after the grant of the marketing authorisation; Conditional fee exemption where scientific advice followed and marketing application is unsuccessful; Assistance with translations of the product information documents. At the end of May 2009, more than 380 companies from 21 countries across the European Economic Area (EEA) had SME status assigned by the EMEA. The large majority of companies are developing medicinal products for human use, 16 are veterinary companies, 15 companies are developing products for both human and veterinary use and 38 are regulatory consultants. Since the SME initiative started the Agency has processed more than 130 requests for scientific advice with fee reductions totalling of 6.9 million euro. Regulatory assistance has been provided to more than 170 companies and 12 companies have benefited from the SME translation service. Stakeholders have acknowledged the significant role the SME Office now plays as a service provider. In the period between January 2006 and June 2009, 34 applications for marketing authorization from SME applicants were filed for medicinal products for human use. Current analysis shows SMEs to have a lower success rate compared to non-SME companies. Major objections for SMEs are particularly high in the area of quality. Although the SME initiative is still at an early stage, it is apparent from the experience gained with applications for marketing authorisation to date that it is important for companies to open up an early dialogue with the EMEA. Scientific advice should be sought early, proactively and comprehensively on key issues in development (quality, non-clinical, clinical) and follow-up advice should be sought as development proceeds. For advanced therapy medicinal products, the assistance available to SMEs will be reinforced in 2009, with the introduction of the certification process.

Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers.

PubMed

Wahid, Rahnuma; Holt, Renee; Hjorth, Richard; Berlanda Scorza, Francesco

2016-10-26

With the support of the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, PATH has contributed to the World Health Organization's (WHO's) Global Action Plan for Influenza Vaccines (GAP) by providing technical and clinical assistance to several developing country vaccine manufacturers (DCVMs). GAP builds regionally based independent and sustainable influenza vaccine production capacity to mitigate the overall global shortage of influenza vaccines. The program also ensures adequate influenza vaccine manufacturing capacity in the event of an influenza pandemic. Since 2009, PATH has worked closely with two DCVMs in Vietnam: the Institute of Vaccines and Medical Biologicals (IVAC) and VABIOTECH. Beginning in 2013, PATH also began working with Torlak Institute in Serbia; Instituto Butantan in Brazil; Serum Institute of India Private Ltd. in India; and Changchun BCHT Biotechnology Co. (BCHT) in China. The DCVMs supported under the GAP program all had existing influenza vaccine manufacturing capability and required technical support from PATH to improve vaccine yield, process efficiency, and product formulation. PATH has provided customized technical support for the manufacturing process to each DCVM based on their respective requirements. Additionally, PATH, working with BARDA and WHO, supported several DCVMs in the clinical development of influenza vaccine candidates progressing toward national licensure or WHO prequalification. As a result of the activities outlined in this review, several companies were able to make excellent progress in developing state-of-the-art manufacturing processes and completing early phase clinical trials. Licensure trials are currently ongoing or planned for several DCVMs. Copyright © 2016 Elsevier Ltd. All rights reserved.

75 FR 4136 - Pipeline Safety: Requests for Special Permit

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-26

... technical analysis or other supporting documentation provided by the requestor, including a description of...: Kay McIver by telephone at (202) 366-0113; or, e-mail at [email protected] . Technical: Steve Nanney...

Risk management measures for chemicals: the "COSHH essentials" approach.

PubMed

Garrod, A N I; Evans, P G; Davy, C W

2007-12-01

"COSHH essentials" was developed in Great Britain to help duty holders comply with the Control of Substances Hazardous to Health (COSHH) Regulations. It uses a similar approach to that described in the new European "REACH" Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals; EC No. 1907/2006 of the European Parliament), insofar as it identifies measures for managing the risk for specified exposure scenarios. It can therefore assist REACH duty holders with the identification and communication of appropriate risk-management measures. The technical basis for COSHH essentials is explained in the original papers published in the Annals of Occupational Hygiene. Its details will, therefore, not be described here; rather, its ability to provide a suitable means for communicating risk-management measures will be explored. COSHH essentials is a simple tool based on an empirical approach to risk assessment and risk management. The output is a "Control Guidance Sheet" that lists the "dos" and "don'ts" for control in a specific task scenario. The guidance in COSHH essentials recognises that exposure in the workplace will depend not just on mechanical controls, but also on a number of other factors, including administrative and behavioural controls, such as systems of work, supervision and training. In 2002, COSHH essentials was made freely available via the internet (http://www.coshh-essentials.org.uk/). This electronic delivery enabled links to be made between product series that share tasks, such as drum filling, and with ancillary guidance, such as setting up health surveillance for work with a respiratory sensitiser. COSHH essentials has proved to be a popular tool for communicating good control practice. It has attracted over 1 million visits to its site since its launch. It offers a common benchmark of good practice for chemical users, manufacturers, suppliers and importers, as well as regulators and health professionals.

Information governance in NHS's NPfIT: a case for policy specification.

PubMed

Becker, Moritz Y

2007-01-01

The National Health Service's (NHS's) National Programme for Information Technology (NPfIT) in the UK with its proposed nation-wide online health record service poses serious technical challenges, especially with regard to access control and patient confidentiality. The complexity of the confidentiality requirements and their constantly evolving nature (due to changes in law, guidelines and ethical consensus) make traditional technologies such as role-based access control (RBAC) unsuitable. Furthermore, a more formal approach is also needed for debating about and communicating on information governance, as natural-language descriptions of security policies are inherently ambiguous and incomplete. Our main goal is to convince the reader of the strong benefits of employing formal policy specification in nation-wide electronic health record (EHR) projects. Many difficulties could be alleviated by specifying the requirements in a formal authorisation policy language such as Cassandra. The language is unambiguous, declarative and machine-enforceable, and is based on distributed constrained Datalog. Cassandra is interpreted within a distributed Trust Management environment, where digital credentials are used for establishing mutual trust between strangers. To demonstrate how policy specification can be applied to NPfIT, we translate a fragment of natural-language NHS specification into formal Cassandra rules. In particular, we present policy rules pertaining to the management of Clinician Sealed Envelopes, the mechanism by which clinical patient data can be concealed in the nation-wide EHR service. Our case study exposes ambiguities and incompletenesses in the informal NHS documents. We strongly recommend the use of trust management and policy specification technology for the implementation of nation-wide EHR infrastructures. Formal policies can be used for automatically enforcing confidentiality requirements, but also for specification and communication purposes. Formalising the requirements also reveals ambiguities and missing details in the currently used informal specification documents.

Use and perception of nitrous oxide sedation by French dentists in private practice: a national survey.

PubMed

Vilanova-Saingery, C; Bailleul-Forestier, I; Vaysse, F; Vergnes, J-N; Marty, M

2017-12-01

The aim of this national survey was to record the use of nitrous oxide and the perceptions of French dental practitioners to this form of sedation. The use of nitrous oxide sedation (NOS) has been authorised in private dental practice in France since December 2009 but, to date, no study implementing both quantitative and qualitative methods has explored such use. The data were collected using a Google Forms questionnaire. A mixed methodology was used for data analysis: a quantitative approach to explore the use of conscious sedation and a qualitative thematic approach (using Nvivo software) to determine the practitioner's perception of it. Responses were collected from 225 practitioners (19% of the target population of 1185). Most of the responders were trained in NOS use in private dental clinics. Seventy-three percent of those who trained privately actually used NOS, compared to 53% of those trained at university (p-value = 0.0052). Above all, NOS was used for children requiring restorative dentistry. The average price of the sedation was 50 Euros and it lasted, on average, for 37 min. The qualitative and thematic analysis revealed the financial and technical difficulties of implementing NOS in private practice. However, it also showed the benefits and pleasure associated with NOS use. This statistical survey of French dental practitioners offers an insight of the current state of the use of conscious sedation with nitrous oxide in private general dental practice in France. It also includes the first report of dental practitioners' perceptions of NOS use and may lead to a better understanding of the reasons why sedation is sometimes not used in private practice.

Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes.

PubMed

Dellepiane, Nora; Pagliusi, Sonia

2018-06-07

The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines' registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. While it also illustrates the divergence of regulatory processes in general, as well as the need to avoid redundant reviews, it does not claim to provide a comprehensive view of all processes nor existing facilitating mechanisms, nor is it intended to touch upon the differences in assessments made by different regulatory authorities. This report describes the work analysed by regulatory experts from vaccine manufacturing companies during a meeting held in Geneva in May 2017, in identifying and quantifying differences in the requirements for vaccine registration in three aspects for comparison: the dossier numbering structure and contents, the application forms, and the evaluation procedures, in different countries and regions. The Module 1 of the Common Technical Document (CTD) of 10 countries were compared. Modules 2-5 of the CTDs of two regions and three countries were compared to the CTD of the US FDA. The application forms of eight countries were compared and the registration procedures of 134 importing countries were compared as well. The analysis indicates a high degree of divergence in numbering structure and content requirements. Possible interventions that would lead to significant improvements in registration efficiency include alignment in CTD numbering structure, a standardised model-application form, and better convergence of evaluation procedures. Copyright © 2018.

Examination of Faculty Expectations of Technical College Administrators as an Important Factor in High Performing Environments

ERIC Educational Resources Information Center

Dupuis, Phyllis A.

2009-01-01

Popular thought supports the notion that faculty expectations of technical college administrators appear to be linked to the success or failure of an institution at accomplishing its mission. These expectations provide the basis for the development of relationships that foster the growth of technical training and thus the growth of a skilled…

75 FR 31433 - Science Advisory Board Staff Office; Notification of a Public Meeting of the SAB Lead Review Panel

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-03

... Lead Review Panel to provide a consultation on EPA's draft technical analyses that will be used to...-to-face meeting to provide a consultation on EPA's draft technical analyses that will be used to... buildings. In the future, EPA will also develop draft technical analyses to support the development of lead...

Career and Technical Education: States Have Broad Flexibility in Implementing Perkins IV. Report to Congressional Requesters. GAO-09-683

ERIC Educational Resources Information Center

Scott, George A.

2009-01-01

The Carl D. Perkins Career and Technical Education Act of 2006 (Perkins IV) supports career and technical education (CTE) in high schools and postsecondary institutions, such as community colleges. Perkins IV established student performance measures at the secondary and postsecondary levels for state agencies, such as state educational agencies,…

NASA Space Environments Technical Discipline Team Space Weather Activities

NASA Astrophysics Data System (ADS)

Minow, J. I.; Nicholas, A. C.; Parker, L. N.; Xapsos, M.; Walker, P. W.; Stauffer, C.

2017-12-01

The Space Environment Technical Discipline Team (TDT) is a technical organization led by NASA's Technical Fellow for Space Environments that supports NASA's Office of the Chief Engineer through the NASA Engineering and Safety Center. The Space Environments TDT conducts independent technical assessments related to the space environment and space weather impacts on spacecraft for NASA programs and provides technical expertise to NASA management and programs where required. This presentation will highlight the status of applied space weather activities within the Space Environment TDT that support development of operational space weather applications and a better understanding of the impacts of space weather on space systems. We will first discuss a tool that has been developed for evaluating space weather launch constraints that are used to protect launch vehicles from hazardous space weather. We then describe an effort to better characterize three-dimensional radiation transport for CubeSat spacecraft and processing of micro-dosimeter data from the International Space Station which the team plans to make available to the space science community. Finally, we will conclude with a quick description of an effort to maintain access to the real-time solar wind data provided by the Advanced Composition Explorer satellite at the Sun-Earth L1 point.

Department of Defense Technical Architecture Framework for Information Management. Volume 1-8: Overview. Version 3.0.

DTIC Science & Technology

1996-04-30

CJCS Chairman of the Joint Chiefs of Staff CMP Configuration Management Plan COTS Commercial-off-the-Shelf DA Data Administrator DASD (IM) Deputy...Staff ( CJCS ) representing the unified combatant commands. " Technical: The system can evolve (migrate) to be supported by the integrated, standards...s) (PSAs), or CJCS , having functional responsibility for the missions and functions supported by the system, with the participation of affected DoD

Population and harvest trends of big game and small game species: a technical document supporting the USDA Forest Service Interim Update of the 2000 RPA Assessment

Treesearch

Curtis H. Flather; Michael S. Knowles; Stephen J. Brady

2009-01-01

This technical document supports the Forest Service's requirement to assess the status of renewable natural resources as mandated by the Forest and Rangeland Renewable Resources Planning Act of 1974 (RPA). It updates past reports on national and regional trends in population and harvest estimates for species classified as big game and small game. The trends...

Final Technical Report: "Achieving Regional Energy Efficiency Potential in the Southeast”

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mahoney, Mandy

The overall objective of this award was to facilitate sharing of DOE resources and best practices as well as provide technical assistance to key stakeholders to support greater compliance with energy efficiency standards and increased energy savings. The outcomes of this award include greater awareness among key stakeholders on energy efficiency topics, increased deployment and utilization of DOE resources, and effective policies and programs to support energy efficiency in the Southeast.

Strategic petroleum reserve supporting research. Quarterly technical report, January 1-March 31, 1986

DOE Office of Scientific and Technical Information (OSTI.GOV)

Woodward, P.W.

1986-01-01

The basic objective is to provide technical support to the Strategic Petroleum Reserve Office (SPRO), through the Bartlesville Project Office. This support includes routine analyses, experimental research, and technical consultation at the SPRO's request. Accomplishments for this past quarter include: stable D, /sup 34/S, and /sup 13/C isotope ratio analyses for 27 samples of SPR crude oil; gas chromatographic simulated distillation (Sim-dis) of 74 SPR crude samples; sim-dis of sludge samples to check for bimodal distributions; data for 8 comprehensive analyses have been entered into the Bonner and Moore ''Crude Assay II'' library; 25 samples which included both whole crudesmore » and distillate fractions were chromatographed using Siemens dual-oven GC and PIANO software; separation of 4 sludge samples into acid, base, and neutral fractions by ion exchange chromatography; and proton and sodium-23 NMR measurements of sludge samples. 1 fig., 5 tabs.« less

Technical communication: Notes toward defining discipline

NASA Technical Reports Server (NTRS)

Rubens, P. M.

1981-01-01

In the field of technical communication, definitions posited in virtually any major text violate every major rule of definitions. The most popular method for defining the field is to state that technical writing is any writing that supports technology or technological activities. There is a need for a nice yardstick for measuring what "technology" is. Some ways in which the field can be defined in a tightly structured empirical way and some implications of technical communication for a humanistic education in a technological age are suggested.

TWRS technical baseline database manager definition document

DOE Office of Scientific and Technical Information (OSTI.GOV)

Acree, C.D.

1997-08-13

This document serves as a guide for using the TWRS Technical Baseline Database Management Systems Engineering (SE) support tool in performing SE activities for the Tank Waste Remediation System (TWRS). This document will provide a consistent interpretation of the relationships between the TWRS Technical Baseline Database Management software and the present TWRS SE practices. The Database Manager currently utilized is the RDD-1000 System manufactured by the Ascent Logic Corporation. In other documents, the term RDD-1000 may be used interchangeably with TWRS Technical Baseline Database Manager.

Non-governmental organizational health operations in humanitarian crises: the case for technical support units.

PubMed

Greenough, P Gregg; Nazerali, Rahim; Fink, Sheri; VanRooyen, Michael J

2007-01-01

As the humanitarian health response industry grows, there is a need for technical health expertise that can build an evidence base around outcome measures and raise the quality and accountability of the health relief response. We propose the formation of technical support units (TSUs), entities of health expertise institutionalized within humanitarian non-governmental organizations (NGOs), which will bridge the gap between the demand for evidence-based, humanitarian programming and the field capacity to accomplish it. With the input of major humanitarian NGOs and donors, this paper discusses the attributes and capacities ofTSUs; and the mechanisms for creating and enhancing TSUs within the NGO management structure.

International Space Station ECLSS Technical Task Agreement Summary Report

NASA Technical Reports Server (NTRS)

Minton-Summers, S.; Ray, C. D.

1996-01-01

A summary of work accomplished under Technical Task Agreement by the Marshall Space Flight Center (MSFC) documents activities regarding the Environmental Control and Life Support Systems (ECLSS) of the International Space Station (ISS) program. These MSFC activities were in-line to the designing, the development, the testing, and the flight of ECLSS equipment. MSFC's unique capabilities for performing integrated system testing and analyses, and its ability to perform some tasks cheaper and faster to support ISS program needs are the basis for the Technical Task Agreement activities. Tasks were completed in the Water Recovery Systems, Air Revitalization Systems, and microbiology areas. The results of each task is described in this summary report.

76 FR 54532 - Pipeline Safety: Request for Special Permit

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-01

... of a technical analysis by the operator. The request and supporting documents were filed at http... telephone at 202-366-0113, or e-mail at [email protected] . Technical: Steve Nanney by telephone at 713-628...

A WET TALE: TOXICITY OF COMPLEX EFFLUENTS

EPA Science Inventory

This course covers standards, regulations, policy, guidance and technical aspects of implementing the whole effluent toxicity program. The curriculum incorporates rationale and information on WET test requirements from USEPA documents, such as the Technical Support Document for W...

DOE Office of Scientific and Technical Information (OSTI.GOV)

This fact provides information on the Strategic Technical Assistance Response Team (START) Program, a U.S. Department of Energy Office of Indian Energy Policy and Programs (DOE-IE) initiative to provide technical expertise to support the development of next-generation energy projects in Indian Country.

Fossil Energy Program

NASA Astrophysics Data System (ADS)

McNeese, L. E.

1981-01-01

Increased utilization of coal and other fossil fuel alternatives as sources of clean energy is reported. The following topics are discussed: coal conversion development, chemical research and development, materials technology, component development and process evaluation studies, technical support to major liquefaction projects, process analysis and engineering evaluations, fossil energy environmental analysis, flue gas desulfurization, solid waste disposal, coal preparation waste utilization, plant control development, atmospheric fluidized bed coal combustor for cogeneration, TVA FBC demonstration plant program technical support, PFBC systems analysis, fossil fuel applications assessments, performance assurance system support for fossil energy projects, international energy technology assessment, and general equilibrium models of liquid and gaseous fuel supplies.

The regulatory acceptance of alternatives in the European Union.

PubMed

Warbrick, E Vicky; Evans, Peter F

2004-06-01

Recently, progress has been made toward the regulatory acceptance of replacements in the European Union (EU), particularly with the introduction of in vitro methods for the prediction of skin corrosivity, dermal penetration, phototoxicity and embryotoxicity. In vitro genotoxicity tests are well established, and testing for this endpoint can be completed without animals, provided that clear negative outcomes are obtained. Tiered approaches including in vitro tests can also be used to address skin and eye irritation endpoints. Reductions and/or refinements in animal use are being achieved following the replacement of the oral LD50 test with alternative methods and the adoption of reduced test packages for materials, such as closed-system intermediates and certain polymers. Furthermore, the use of a "read-across" approach has reduced animal testing. Substantial gains in refinement will also be made with the recent acceptance of the local lymph node assay for skin sensitisation and the development of an acute inhalation toxicity method that avoids lethality as the endpoint. For the future, under the proposed EU Registration, Evaluation and Authorisation of Chemicals (REACH) scheme, it is envisaged that, where suitable in vitro methods exist, these should be used to support registration of substances produced at up to ten tonnes per annum. This proposal can only accelerate the further development, validation and regulatory acceptance of such alternative methods.

Towards a more transparent HTA process in Poland: new Polish HTA methodological guidelines

PubMed Central

Lach, Krzysztof; Dziwisz, Michal; Rémuzat, Cécile; Toumi, Mondher

2017-01-01

ABSTRACT Introduction: Health technology assessment (HTA) in Poland supports reimbursement decisions via the Polish HTA Agency (AOTMiT), whose guidelines were updated in 2016. Methods: We identified key changes introduced by the update and, before guideline publication, analysed discrepancies between AOTMiT assessments and the submitting marketing authorisation holders (MAHs) to elucidate the context of the update. We compared the clarity and detail of the new guidelines versus those of the UK’s National Institute for Health and Care Excellence (NICE). Results: The update specified more precise requirements for items such as indirect comparison or input data for economic modelling. Agency–MAH discrepancies relating to the subjects of the HTA update were found in 14.6% of published documents. The new Polish HTA guidelines were as clear and detailed as NICE’s on topics such as assessing quality of evidence and economic modelling, but were less informative when describing (for example) pairwise meta-analysis. Conclusions: The Polish HTA guidelines update demonstrates lessons learned from internal and external experiences. The new guidelines adhere more closely to UK HTA standards, being clearer and more informative. While the update is expected to reduce Agency–MAH discrepancies, there remain areas for development, such as providing templates to aid HTA submissions. PMID:28804603

Grouping of Petroleum Substances as Example UVCBs by Ion Mobility-Mass Spectrometry to Enable Chemical Composition-Based Read-Across.

PubMed

Grimm, Fabian A; Russell, William K; Luo, Yu-Syuan; Iwata, Yasuhiro; Chiu, Weihsueh A; Roy, Tim; Boogaard, Peter J; Ketelslegers, Hans B; Rusyn, Ivan

2017-06-20

Substances of Unknown or Variable composition, Complex reaction products, and Biological materials (UVCBs), including many refined petroleum products, present a major challenge in regulatory submissions under the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and US High Production Volume regulatory regimes. The inherent complexity of these substances, as well as variability in composition obfuscates detailed chemical characterization of each individual substance and their grouping for human and environmental health evaluation through read-across. In this study, we applied ion mobility mass spectrometry in conjunction with cheminformatics-based data integration and visualization to derive substance-specific signatures based on the distribution and abundance of various heteroatom classes. We used petroleum substances from four petroleum substance manufacturing streams and evaluated their chemical composition similarity based on high-dimensional substance-specific quantitative parameters including m/z distribution, drift time, carbon number range, and associated double bond equivalents and hydrogen-to-carbon ratios. Data integration and visualization revealed group-specific similarities for petroleum substances. Observed differences within a product group were indicative of batch- or manufacturer-dependent variation. We demonstrate how high-resolution analytical chemistry approaches can be used effectively to support categorization of UVCBs based on their heteroatom composition and how such data can be used in regulatory decision-making.

Applications of AOPs to ecotoxicology | Science Inventory | US ...

EPA Pesticide Factsheets

Toxicologists conducting safety assessments for either human or ecological health are responsible for generating data for possible adverse effects of a rapidly increasing number of substances. For example, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) program in Europe, and the recent reauthorization of the Toxic Substances Control Act (TSCA) in the United States (US) both explicitly mandate consideration of the potential toxicity of many thousands of chemicals that, in the past, would not have been assessed. There also is an increasing emphasis on understanding the effects of existing chemical mixtures on human health and the environment; for example in North America, the Great Lakes Restoration Initiative, sponsored by the Office of the President of the US, has identified complex mixtures of chemicals of emerging concern as one of the highest priority stressors in the lakes. These types of new regulatory programs and monitoring initiatives highlight the necessity of identifying and developing novel, rapid approaches for assessing the potential toxicity of substances, to augment (or, in some instances, replace) the more costly, long-term in vivo test methods that historically have supported chemical risk assessments. Fortunately, these chemical evaluation challenges are occurring against a backdrop of evolving data collection and analysis techniques that enable generation of biological information in manners previously conside

Regulatory pathways to enable the licencing of alternatives to antibiotics.

PubMed

Ioannou, Faye; Burnsteel, Cindy; Mackay, David K J; Gay, Cyril G

2018-05-01

Effective alternatives to antibiotics (ATA) such as vaccines, antibodies, phage therapies, prebiotics, probiotics and herbal medicines can be used in place of traditional antibiotics in a way that does not compromise animal health as means of tackling the growing threat to both animal and human health from antimicrobial resistance (AMR). This paper reflects the key points on the approaches that were discussed during the 2nd International Symposium on ATA between regulatory agencies, veterinary product companies representing largely the pharmaceutical and feed-additive sectors, academia and other stakeholders on regulatory pathways to enable the licensing of alternatives to antibiotics for food producing animals. The need to demonstrate compliance with generally accepted standards for quality, safety and efficacy is considered a pre-requisite for all veterinary medicinal products receiving an authorisation including ATA, irrespective of the region in which they are approved. ATA are often based on novel technologies, with complex mechanisms of action; therefore, early and close communication with regulators is encouraged. In addition, strategic use by ATA applicants of all regulatory tools available to support innovation is highly recommended. The veterinary product manufacturers consider that the regulation of veterinary medicines should evolve to accommodate innovative ATA technologies and incentives from regulatory agencies provided to stimulate further ATA development. Copyright © 2018.

EGI-EUDAT integration activity - Pair data and high-throughput computing resources together

NASA Astrophysics Data System (ADS)

Scardaci, Diego; Viljoen, Matthew; Vitlacil, Dejan; Fiameni, Giuseppe; Chen, Yin; sipos, Gergely; Ferrari, Tiziana

2016-04-01

EGI (www.egi.eu) is a publicly funded e-infrastructure put together to give scientists access to more than 530,000 logical CPUs, 200 PB of disk capacity and 300 PB of tape storage to drive research and innovation in Europe. The infrastructure provides both high throughput computing and cloud compute/storage capabilities. Resources are provided by about 350 resource centres which are distributed across 56 countries in Europe, the Asia-Pacific region, Canada and Latin America. EUDAT (www.eudat.eu) is a collaborative Pan-European infrastructure providing research data services, training and consultancy for researchers, research communities, research infrastructures and data centres. EUDAT's vision is to enable European researchers and practitioners from any research discipline to preserve, find, access, and process data in a trusted environment, as part of a Collaborative Data Infrastructure (CDI) conceived as a network of collaborating, cooperating centres, combining the richness of numerous community-specific data repositories with the permanence and persistence of some of Europe's largest scientific data centres. EGI and EUDAT, in the context of their flagship projects, EGI-Engage and EUDAT2020, started in March 2015 a collaboration to harmonise the two infrastructures, including technical interoperability, authentication, authorisation and identity management, policy and operations. The main objective of this work is to provide end-users with a seamless access to an integrated infrastructure offering both EGI and EUDAT services and, then, pairing data and high-throughput computing resources together. To define the roadmap of this collaboration, EGI and EUDAT selected a set of relevant user communities, already collaborating with both infrastructures, which could bring requirements and help to assign the right priorities to each of them. In this way, from the beginning, this activity has been really driven by the end users. The identified user communities are relevant European Research infrastructure in the field of Earth Science (EPOS and ICOS), Bioinformatics (BBMRI and ELIXIR) and Space Physics (EISCAT-3D). The first outcome of this activity has been the definition of a generic use case that captures the typical user scenario with respect the integrated use of the EGI and EUDAT infrastructures. This generic use case allows a user to instantiate a set of Virtual Machine images on the EGI Federated Cloud to perform computational jobs that analyse data previously stored on EUDAT long-term storage systems. The results of such analysis can be staged back to EUDAT storages, and if needed, allocated with Permanent identifyers (PIDs) for future use. The implementation of this generic use case requires the following integration activities between EGI and EUDAT: (1) harmonisation of the user authentication and authorisation models, (2) implementing interface connectors between the relevant EGI and EUDAT services, particularly EGI Cloud compute facilities and EUDAT long-term storage and PID systems. In the presentation, the collected user requirements and the implementation status of the universal use case will be showed. Furthermore, how the universal use case is currently applied to satisfy EPOS and ICOS needs will be described.

Improving non-technical skills (teamwork) in post-partum haemorrhage: A grouped randomised trial.

PubMed

Letchworth, Pippa M; Duffy, Shane P; Phillips, Dan

2017-10-01

To determine the effect of a decision support technology on teamwork and associated non-technical (NTS) and technical skills when teams manage post-partum haemorrhage (PPH) in the simulated environment. Multidisciplinary (MDT) maternity teams were taught how to manage post partum haemorrhage. They were randomised to the intervention: using a decision support mobile digital platform or a control group. Each team managed a post-partum simulation, which was recorded and reviewed by assessors. Primary outcome measures to assess teams NTS were the validated Global Assessment of Obstetric Team Performance (GAOTP) and Clinical Teamwork Scale (CTS). Secondary outcome measures were the 'friends and family test', technical skills, and the System Usability Scale (SUS). Sample size estimation was calculated by using 80% power 5% significance two tailed test (p1=85% p2=40%) n=34. 38 teams from August 2014-February 2016, were recruited, technical issues with failure of recording equipment meant 4 teams were excluded from teamwork analysis (1 intervention 3 control). Teamwork improved across all domains with the intervention (using a decision support mobile digital platform) p <0.01. CTS improved between 6.7-16.8% (average 14.2%) and GAOTP between 8.6-17.1% (average 13.5%) for all domains. Using the control group as baseline, the intervention improved teamwork by 25% using CTS and 22% using GAOTP. Fewer technical skills were missed with the intervention (p<0.01). There was no statistical difference in the time technical skills were achieved. Assessors were more likely to recommend intervention teams 87.5% (77/88) than control teams 63.6% (56/88) p<0.01 to their friends or family. The SUS was 'Good' (69) becoming excellently 'Usable' (81.6) over the study period. We report a decision support system, which improved NTS when managing PPH. Lack of teamwork is often cited as the cause of failures in care and we report a usable technology that assists with and improves teamwork during an emergency. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects and effectiveness of dynamic arm supports: a technical review.

PubMed

van der Heide, Loek A; Gelderblom, Gert Jan; de Witte, Luc P

2015-01-01

Numerous dynamic arm supports have been developed in recent decades to increase independence in the performance of activities of daily living. Much effort and money have been spent on their development and prescription, yet insight into their effects and effectiveness is lacking. This article is a systematic review of evaluations of dynamic arm supports. The 8 technical evaluations, 12 usability evaluations, and 27 outcome studies together make 47 evaluations. Technical evaluations were often used as input for new developments and directed at balancing quality, forces and torques, and range of motion of prototypes. Usability studies were mostly single-measure designs that had varying results as to whether devices were usable for potential users. An increased ability to perform activities of daily living and user satisfaction were reported in outcome studies. However, the use of dynamic arm supports in the home situation was reported to be low. Gaining insight into why devices are not used when their developers believe them to be effective seems crucial for every new dynamic arm support developed. The methodological quality of the outcome studies was often low, so it is important that this is improved in the future.

Technical Revisions to State Budgets and New Unit Set-Asides TSD

EPA Pesticide Factsheets

EPA proposed revising the Transport Rule's new unit set-asides (NUSAs) in certain states. This technical support document (TSD) shows underlying data and calculations and provides the information used to determine revised NUSAs in certain states.

DOE Office of Scientific and Technical Information (OSTI.GOV)

This fact sheet provides information on the Tribes selected to receive assistance from the U.S. Department of Energy Office of Indian Energy 2013 Strategic Technical Assistance Response Team (START) Program, which provides technical expertise to support the development of next-generation energy projects on tribal lands.

EPA Partners with Maine DEP to Provide Technical Assistance Support, Improve Environmental and Public Health in Maine

EPA Pesticide Factsheets

The US Environmental Protection Agency (EPA) Region 1 is collaborating with the Maine Department of Environmental Protection (ME DEP) to provide free technical assistance for municipalities and businesses in Maine.

A formative evaluation of a coach-based technical assistance model for youth- and family-focused programming.

PubMed

Olson, Jonathan R; McCarthy, Kimberly J; Perkins, Daniel F; Borden, Lynne M

2018-04-01

The Children, Youth, and Families At-Risk (CYFAR) initiative provides funding and technical support for local community-based programs designed to promote positive outcomes among vulnerable populations. In 2013, CYFAR implemented significant changes in the way it provides technical assistance (TA) to grantees. These changes included introducing a new TA model in which trained coaches provide proactive support that is tailored to individual CYFAR projects. The purpose of this paper is to describe the evolution of this TA model and present preliminary findings from a formative evaluation. CYFAR Principal Investigators (PIs) were invited to respond to online surveys in 2015 and 2016. The surveys were designed to assess PI attitudes towards the nature and quality of support that they receive from their coaches. CYFAR PIs reported that their coaches have incorporated a range of coaching skills and techniques into their work. PIs have generally positive attitudes towards their coaches, and these attitudes have become more positive over time. Results suggest that CYFAR PIs have been generally supportive of the new TA system. Factors that may have facilitated support include a strong emphasis on team-building and the provision of specific resources that support program design, implementation, and evaluation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Technical Assistance and Changes in Nutrition and Physical Activity Practices in the National Early Care and Education Learning Collaboratives Project, 2015–2016

PubMed Central

Smith, Teresa M.; Estabrooks, Paul A.; Rasmussen, Cristy Geno; Blaser, Casey; Yaroch, Amy L

2018-01-01

Purpose and Objectives The National Early Care and Education Learning Collaboratives Project (ECELC) aims to improve best practices in early care and education (ECE) programs in topic areas of the Nutrition and Physical Activity Self-Assessment in Child Care (NAP SACC). Technical assistance is a component of the ECELC, yet its effect on outcomes is unclear. Beyond dose and duration of technical assistance, limited research exists on characteristics of technical assistance that contribute to outcomes. The objective of this study was to identify and describe technical assistance characteristics and explore associations with NAP SACC outcomes. Intervention Approach We collected data from 10 collaboratives comprising 84 ECE programs in 2 states in 2015–2016. The objective of technical assistance was to support programs in improving best practices. Technical assistance was provided to programs via on-site, telephone, or email and was tailored to program needs. Evaluation Methods We used a mixed-methods design to examine associations between technical assistance and NAP SACC outcomes. We used multiple regression analysis to assess quantitative data and qualitative comparative analysis to determine necessary and sufficient technical assistance conditions supporting NAP SACC outcomes. We also conducted a document review to describe technical assistance that referred conditions identified by the qualitative comparative analysis. Results Regression analyses detected an inverse relationship between changes in NAP SACC scores and hours of technical assistance. No clear pattern emerged in the qualitative comparative analysis, leaving no necessary and sufficient conditions. However, the qualitative comparative analysis identified feedback as a potentially important component of technical assistance, whereas resource sharing and frequent email were characteristics that seemed to reduce the likelihood of improved outcomes. Email and resource sharing were considered primarily general information rather than tailored technical assistance. Implications for Public Health Technical assistance may be used in programs and made adaptable to program needs. The inclusion and evaluation of technical assistance, especially tailored approaches, is warranted for environmental interventions, including ECE settings. PMID:29704371

75 FR 6030 - EPA Science Advisory Board Staff Office Request for Nominations of Experts for the SAB Lead (Pb...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... requesting public nominations of experts to form an SAB Ad Hoc Panel to review EPA's draft technical analyses... residential dust. OPPT is developing draft technical analyses that will be used to support: (a) Possible... that the SAB conduct a review of these draft technical analyses. The SAB was established by 42 U.S.C...

Socio-Technical Deliberation about Free and Open Source Software: Accounting for the Status of Artifacts in Public Life

ERIC Educational Resources Information Center

Benoit-Barne, Chantal

2007-01-01

This essay investigates the rhetorical practices of socio-technical deliberation about free and open source (F/OS) software, providing support for the idea that a public sphere is a socio-technical ensemble that is discursive and fluid, yet tangible and organized because it is enacted by both humans and non-humans. In keeping with the empirical…

An Assessment of the Support Service Needs of Career and Technical Education Teachers and Their Students with Limited English Proficiency in Selected Pennsylvania AVTS's

ERIC Educational Resources Information Center

Wichowski, Chester P.; Nunez, Frances

2005-01-01

A survey was conducted among a population of 350 Career and Technical Education, CTE, teachers from 12 Career Technical Education Centers, CTC, sites in seven counties throughout Pennsylvania (return rate = 64%). The participating schools demographic settings, which were selected by the respondents, were closely divided between rural (37.9%) and…

Oral surgery in the European Union: challenges of diversity in training and practice.

PubMed

Nasseripour, M N; Hervé, C; Meningaud, J-P

2017-02-01

At the crossroads of medicine and dentistry, oral surgery with orthodontics are the only recognised dental specialties by the European Union. The goal of our study is to evaluate the current state of oral surgery in Europe from its teaching to its practice, the hypothesis being that a notable diversity persists despite European Union harmonisation process. To understand the impact of this diversity applied to European Union freedom of movement and its ethical implications for the practice of oral surgery, English and French questionnaires were sent by email to universities and organisations delivering authorisation to practise in France, Germany, Spain, Sweden and United Kingdom chosen based upon inclusion and exclusion criteria. An analysis of documents on these organisations' official websites was also conducted. Demographic information was obtained from the aforementioned organisations. The profile of practising oral surgeons is different dependent on the country. The university and hospital trainings conform to European recommendations and span 3-4 years. European Board certification is not required. Continuing education is mandatory only in France, Germany and United Kingdom. As for curricula and scope of practice, no consensus can be derived. There is potential conflict of interest between European Union principles of freedom of movement and protection of all citizens, as member countries do not uniformly apply Directives and recommendations. A new survey of all European Union oral surgery programmes as well as organisations delivering authorisation to practise is necessary to implement across the board harmonisation of training and practice to insure patient safety in light of the migration of European Union practitioners. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Scoping study into wound management nurse practitioner models of practice.

PubMed

Gibb, Michelle A; Edwards, Helen E; Gardner, Glenn E

2015-04-01

The primary objective of this research was to investigate wound management nurse practitioner (WMNP) models of service for the purposes of identifying parameters of practice and how patient outcomes are measured. A scoping study was conducted with all authorised WMNPs in Australia from October to December 2012 using survey methodology. A questionnaire was developed to obtain data on the role and practice parameters of authorised WMNPs in Australia. The tool comprised seven sections and included a total of 59 questions. The questionnaire was distributed to all members of the WMNP Online Peer Review Group, to which it was anticipated the majority of WMNPs belonged. Twenty-one WMNPs responded (response rate 87%), with the results based on a subset of respondents who stated that, at the time of the questionnaire, they were employed as a WMNP, therefore yielding a response rate of 71% (n=15). Most respondents (93%; n=14) were employed in the public sector, with an average of 64 occasions of service per month. The typical length of a new case consultation was 60 min, with 32 min for follow ups. The most frequently performed activity was wound photography (83%; n=12), patient, family or carer education (75%; n=12), Doppler ankle-brachial pressure index assessment (58%; n=12), conservative sharp wound debridement (58%; n=12) and counselling (50%; n=12). The most routinely prescribed medications were local anaesthetics (25%; n=12) and oral antibiotics (25%; n=12). Data were routinely collected by 91% of respondents on service-related and wound-related parameters to monitor patient outcomes, to justify and improve health services provided. This study yielded important baseline information on this professional group, including data on patient problems managed, the types of interventions implemented, the resources used to accomplish outcomes and how outcomes are measured.

Quality of alcohol-based hand disinfectants and their regulatory status. Development and marketing authorisation.

PubMed

Stengele, Michael

2008-10-01

A 2005 survey showed that there are at least four legal product classifications for hand disinfectants in the European Union: medicinal products, biocidal products, cosmetics and medical devices. An internationally harmonized classification does not exist. The regulatory status of those products is defined at national level. In order to assure compliance with the regulations these four classifications provide different levels of official surveillance varying from product-specific marketing authorisations and production site audits to the obligation to just work in accordance with certain general guidelines. Biocidal product regulations cover eco-toxicological and toxicological aspects, but do not very much address to the customers' quality and efficacy expectations. In contrast, the medicinal product legislation is the most ambitious one claiming quality, safety, efficacy, and an independent benefit risk-assessment by an authority. In respect of ambition, the two remaining product categories--cosmetics and medical devices--rank between the both classifications mentioned above. For medical devices, it is the responsibility of the manufacturer to make sure the products meet defined essential requirements regarding quality, safety and performance and to have an appropriate quality assurance system implemented under third party control. For cosmetics there are some legal restrictions, but within these it is the sole responsibility of the manufacturer to ensure that the products are safe and fulfil their claims. This paper describes one way out of this increasingly complex situation, the definition of a single quality standard meeting the users' expectations as well as all legal requirements regardless of the specific sales country. This international quality standard for products would take priority over any individual national standard, to the benefit of users.

[Ten years experience with the first approved biosimilar recombinant human growth hormone drug in normal clinical practice].

PubMed

López-Siguero, Juan Pedro; Palla García, Margarida; Martínez Busto, Elena; Rebollo, Francisco José; Pombo, Manuel

2018-04-01

Recombinant human growth hormone (rhGH) is the first biosimilar drug approved by the European Medicines Agency in 2006, using the biosimilar registration process. It was authorised for the treatment of growth hormone deficiency, and growth disorders associated with Turner's syndrome, chronic renal failure, Prader-Willi syndrome, and growth disorders in children/adolescents born small for gestational age, and replacement therapy in adults with pronounced growth hormone deficiency. This review is focused on the scientific evidence published about this drug in the last ten years, including the clinical trials on which the approval of the regulatory authority is based, and the most relevant studies evaluating the clinical impact of the drug in clinical practice. The equivalence between biosimilar and original product has been confirmed in the clinical trials published by Romer et al. and López-Siguero et al. Furthermore, studies carried out in real-life conditions confirm its long-term efficacy and safety, as well as the absence of clinical impact by switching treatment from the original to the biosimilar product. The number of patients receiving this medication has continuously increased since its approval. Its equivalence with the original product has been verified. Preliminary data from the post-authorisation PATRO study confirm the efficacy and safety of the biosimilar product in comparison with data from clinical trials. However, final results must be evaluated at the end of the study, which will provide additional information about the long-term efficacy and safety of the biosimilar drug. Copyright © 2016 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view.

PubMed

Cohet, Catherine; Rosillon, Dominique; Willame, Corinne; Haguinet, Francois; Marenne, Marie-Noëlle; Fontaine, Sandrine; Buyse, Hubert; Bauchau, Vincent; Baril, Laurence

2017-05-25

Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates. Study settings include the use of large healthcare databases and de novo data collection. PASS methodology is influenced by the background incidence of the outcome of interest, vaccine uptake, availability and quality of data sources, identification of the at-risk population and of suitable comparators, availability of validated case definitions, and the frequent need for case ascertainment in large databases. Challenges include the requirement for valid exposure and outcome data, identification of, and access to, adequate data sources, and mitigating limitations including bias and confounding. Assessing feasibility is becoming a key step to confirm that study objectives can be met in a timely manner. PASS provide critical information for regulators, public health agencies, vaccine manufacturers and ultimately, individuals. Collaborative approaches and synergistic efforts between vaccine manufacturers and key stakeholders, such as regulatory and public health agencies, are needed to facilitate access to data, and to drive optimal study design and implementation, with the aim of generating robust evidence. Copyright © 2017 GSK Biologicals SA. Published by Elsevier Ltd.. All rights reserved.

Comparison of not for resuscitation (NFR) forms across five Victorian health services.

PubMed

Levinson, M; Mills, A; Hutchinson, A M; Heriot, G; Stephenson, G; Gellie, A

2014-07-01

Within Australian hospitals, cardiac and respiratory arrests result in a resuscitation attempt unless the patient is documented as not for resuscitation. To examine the consistency of policies and documentation for withholding in-hospital resuscitation across health services. An observational, qualitative review of hospital policy and documentation was conducted in June 2013 in three public and two private sector hospitals in metropolitan Melbourne. Not for resuscitation (NFR) forms were evaluated for physical characteristics, content, authorisation and decision-making. Hospital policies were coded for alerts, definition of futility and burden of treatment and management of discussions and dissent. There was a lack of standardisation, with each site using its own unique NFR form and accompanying site-specific policies. Differences were found in who could authorise the decision, what was included on the form, the role of patients and families, and how discussions were managed and dissent resolved. Futility and burden of treatment were not defined independently. These inconsistencies across sites contribute to a lack of clarity regarding the decision to withhold resuscitation, and have implications for staff employed across multiple hospitals. NFR forms should be reviewed and standardised so as to be clear, uniform and consistent with the legislative framework. We propose a two-stage process of documentation. Stage 1 facilitates discussion of patient-specific goals of care and consideration of limitations of treatment. Stage 2 serves to communicate a NFR order. Decisions to withhold resuscitation are inherently complex but could be aided by separating the decision-making process from the communication of the decision, resulting in improved end-of-life care. © 2014 The Authors; Internal Medicine Journal © 2014 Royal Australasian College of Physicians.

Profitability and Market Value of Orphan Drug Companies: A Retrospective, Propensity-Matched Case-Control Study.

PubMed

Hughes, Dyfrig A; Poletti-Hughes, Jannine

2016-01-01

Concerns about the high cost of orphan drugs has led to questions being asked about the generosity of the incentives for development, and associated company profits. We conducted a retrospective, propensity score matched study of publicly-listed orphan companies. Cases were defined as holders of orphan drug market authorisation in Europe or the USA between 2000-12. Control companies were selected based on their propensity for being orphan drug market authorisation holders. We applied system General Method of Moments to test whether companies with orphan drug market authorization are valued higher, as measured by the Tobin's Q and market to book value ratios, and are more profitable based on return on assets, than non-orphan drug companies. 86 companies with orphan drug approvals in European (4), USA (61) or both (21) markets were matched with 258 controls. Following adjustment, orphan drug market authorization holders have a 9.6% (95% confidence interval, 0.6% to 18.7%) higher return on assets than non-orphan drug companies; Tobin's Q was higher by 9.9% (1.0% to 19.7%); market to book value by 15.7% (3.1% to 30.0%) and operating profit by 516% (CI 19.8% to 1011%). For each additional orphan drug sold, return on assets increased by 11.1% (0.6% to 21.3%), Tobin's Q by 2.7% (0.2% to 5.2%), and market to book value ratio by 5.8% (0.7% to 10.9%). Publicly listed pharmaceutical companies that are orphan drug market authorization holders are associated with higher market value and greater profits than companies not producing treatments for rare diseases.

Profitability and Market Value of Orphan Drug Companies: A Retrospective, Propensity-Matched Case-Control Study

PubMed Central

Hughes, Dyfrig A.; Poletti-Hughes, Jannine

2016-01-01

Background Concerns about the high cost of orphan drugs has led to questions being asked about the generosity of the incentives for development, and associated company profits. Methods We conducted a retrospective, propensity score matched study of publicly-listed orphan companies. Cases were defined as holders of orphan drug market authorisation in Europe or the USA between 2000–12. Control companies were selected based on their propensity for being orphan drug market authorisation holders. We applied system General Method of Moments to test whether companies with orphan drug market authorization are valued higher, as measured by the Tobin’s Q and market to book value ratios, and are more profitable based on return on assets, than non-orphan drug companies. Results 86 companies with orphan drug approvals in European (4), USA (61) or both (21) markets were matched with 258 controls. Following adjustment, orphan drug market authorization holders have a 9.6% (95% confidence interval, 0.6% to 18.7%) higher return on assets than non-orphan drug companies; Tobin’s Q was higher by 9.9% (1.0% to 19.7%); market to book value by 15.7% (3.1% to 30.0%) and operating profit by 516% (CI 19.8% to 1011%). For each additional orphan drug sold, return on assets increased by 11.1% (0.6% to 21.3%), Tobin’s Q by 2.7% (0.2% to 5.2%), and market to book value ratio by 5.8% (0.7% to 10.9%). Conclusions Publicly listed pharmaceutical companies that are orphan drug market authorization holders are associated with higher market value and greater profits than companies not producing treatments for rare diseases. PMID:27768685

An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe.

PubMed

Ebbers, Hans C; Langedijk, Joris; Bouvy, Jacoline C; Hoekman, Jarno; Boon, Wouter P C; de Jong, Jean Philippe; De Bruin, Marie L

2015-10-01

The aim of this study is to provide a comprehensive overview of the outcomes of marketing authorisation applications via the mutual recognition and decentralised procedures (MRP/DCP) and assess determinants of licensing failure during CMDh referral procedures. All MRP/DCP procedures to the Co-ordination group for Mutual recognition and Decentralised procedures-human (CMDh) during the period from January 2006 to December 2013 were analysed. Reasons for starting referral procedures were scored. In addition, a survey under pharmaceutical companies was performed to estimate the frequency of licensing failure prior to CMDh referrals. During the study period, 10392 MRP/DCP procedures were finalized. Three hundred seventy-seven (3.6%) resulted in a referral procedure, of which 70 (19%) resulted in licensing failure, defined as refusal or withdrawal of the application. The frequency of CMDh referrals decreased from 14.5% in 2006 to 1.6% in 2013. Of all referrals, 272 (72%) were resolved through consensus within the CMDh, the remaining 105 (28%) were resolved at the level of the CHMP. Most referrals were started because of objections raised about the clinical development program. Study design issues and objections about the demonstration of equivalence were most likely to result in licensing failure. An estimated 11% of all MRP/DCP procedures resulted in licensing failure prior to CMDh referral. Whereas the absolute number of MRP/DCP procedures resulting in a referral has reduced substantially over the past years, no specific time trend could be observed regarding the frequency of referrals resulting in licensing failure. Increased knowledge at the level of companies and regulators has reduced the frequency of late-stage failure of marketing applications via the MRP/DCP.

May I see your ID, please? An explorative study of the professional identity of undergraduate medical education leaders.

PubMed

Sundberg, Kristina; Josephson, Anna; Reeves, Scott; Nordquist, Jonas

2017-02-01

The mission of undergraduate medical education leaders is to strive towards the enhancement of quality of medical education and health care. The aim of this qualitative study is, with the help of critical perspectives, to contribute to the research area of undergraduate medical education leaders and their identity formation; how can the identity of undergraduate medical education leaders be defined and further explored from a power perspective? In this explorative study, 14 educational leaders at a medical programme in Scandinavia were interviewed through semi-structured interviews. The data was analysed through Moustakas' structured, phenomenological analysis approach and then pattern matched with Gee's power-based identity model. Educational leaders identify themselves more as mediators than leaders and do not feel to any larger extent that their professional identity is authorised by the university. These factors potentially create difficulties when trying to communicate with medical teachers, often also with a weaker sense of professional identity, about medical education. The perceptions of the professional identity of undergraduate medical education leaders provide us with important notions on the complexities on executing their important mission to develop medical education: their perceptions of ambiguity towards the process of trying to lead teachers toward educational development and a perceived lack of authorisation of their work from the university level. These are important flaws to observe and correct when improving the context in which undergraduate medical education leaders are trying to develop and improve undergraduate medical programmes. A practical outcome of the results of this study is the facilitation of design of faculty development programmes for educational leaders in undergraduate medial education.

Tensions between policy and practice: A qualitative analysis of decisions regarding compulsory admission to psychiatric hospital.

PubMed

Fistein, Elizabeth C; Clare, Isabel C H; Redley, Marcus; Holland, Anthony J

2016-01-01

The use of detention for psychiatric treatment is widespread and sometimes necessary. International human rights law requires a legal framework to safeguard the rights to liberty and personal integrity by preventing arbitrary detention. However, research suggests that extra-legal factors may influence decisions to detain. This article presents observational and interview data to describe how decisions to detain are made in practice in one jurisdiction (England and Wales) where a tension between policy and practice has been described. The analysis shows that practitioners mould the law into 'practical criteria' that appear to form a set of operational criteria for identifying cases to which the principle of soft paternalism may be applied. Most practitioners also appear willing, albeit often reluctantly, to depart from their usual reliance on the principle of soft paternalism and authorise detention of people with the capacity to refuse treatment, in order to prevent serious harm. We propose a potential resolution for the tension between policy and practice: two separate legal frameworks to authorise detention, one with a suitable test of capacity, used to enact soft paternalism, and the other to provide legal justification for detention for psychiatric treatment of the small number of people who retain decision-making capacity but nonetheless choose to place others at risk by refusing treatment. This separation of detention powers into two systems, according to the principle that justifies the use of detention would be intellectually coherent, consistent with human rights instruments and, being consistent with the apparent moral sentiments of practitioners, less prone to idiosyncratic interpretations in practice. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

H2 at Scale: Benefitting our Future Energy System - Update for the Hydrogen Technical Advisory Committee

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ruth, Mark

2016-12-06

Hydrogen is a flexible, clean energy carrying intermediate that enables aggressive market penetration of renewables while deeply decarbonizing our energy system. H2 at Scale is a concept that supports the electricity grid by utilizing energy without other demands at any given time and also supports transportation and industry by providing low-priced hydrogen to them. This presentation is an update to the Hydrogen Technical Advisory Committee (HTAC).

Technical support documentation for the Automated Residential Energy Standard (ARES) in support of proposed interim energy conservation voluntary performance standards for new non-federal residential buildings: Volume 2

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The Automated Residential Energy Standard (ARES) program is designed to identify levels of thermal integrity (e.g., insulation levels, glazing layers, equipment efficiencies, etc.) that are cost effective for typical residential structures and to create a residential energy standard based on these levels. This document contains technical background the explains the data and the algorithms used by the program.

Decision Support | Solar Research | NREL

Science.gov Websites

informed solar decision making with credible, objective, accessible, and timely resources. Solar Energy Decision Support Decision Support NREL provides technical and analytical support to support provide unbiased information on solar policies and issues for state and local government decision makers

Reducing the vulnerability of young Cambodians to HIV / STDs by mobilising and strengthening local NGO sector. RAS/88/P15.

PubMed

1999-06-01

This project seeks to help reduce the vulnerability of young Cambodians aged 12-25 to HIV/AIDS and sexually transmitted diseases (STDs) by strengthening nongovernmental organization (NGO) capacity to develop sustainable, effective and appropriate responses to HIV/AIDS and STDs. The strategies include strengthening local NGO capacity, sharing technical support concerning HIV/AIDS, and working together to develop information, education and communication on HIV/AIDS. Main activities included in the project are: 1) enable NGOs to undertake broader response to HIV/STDs by mobilizing, selecting, contracting, monitoring and supervising local NGO projects; 2) enhance local NGO capacity to work with the youth by organizing specialist training workshops, providing technical support and training in external relations and sustainability, and promoting local NGO/youth volunteer exchange and exposure programs; 3) strengthen the capacity of local NGOs through training, skill building, technical support and development of NGO support program; and 4) improve the knowledge base of programming for youth by identifying, documenting and disseminating effective programming models and tools.

Space and Earth Sciences, Computer Systems, and Scientific Data Analysis Support, Volume 1

NASA Technical Reports Server (NTRS)

Estes, Ronald H. (Editor)

1993-01-01

This Final Progress Report covers the specific technical activities of Hughes STX Corporation for the last contract triannual period of 1 June through 30 Sep. 1993, in support of assigned task activities at Goddard Space Flight Center (GSFC). It also provides a brief summary of work throughout the contract period of performance on each active task. Technical activity is presented in Volume 1, while financial and level-of-effort data is presented in Volume 2. Technical support was provided to all Division and Laboratories of Goddard's Space Sciences and Earth Sciences Directorates. Types of support include: scientific programming, systems programming, computer management, mission planning, scientific investigation, data analysis, data processing, data base creation and maintenance, instrumentation development, and management services. Mission and instruments supported include: ROSAT, Astro-D, BBXRT, XTE, AXAF, GRO, COBE, WIND, UIT, SMM, STIS, HEIDI, DE, URAP, CRRES, Voyagers, ISEE, San Marco, LAGEOS, TOPEX/Poseidon, Pioneer-Venus, Galileo, Cassini, Nimbus-7/TOMS, Meteor-3/TOMS, FIFE, BOREAS, TRMM, AVHRR, and Landsat. Accomplishments include: development of computing programs for mission science and data analysis, supercomputer applications support, computer network support, computational upgrades for data archival and analysis centers, end-to-end management for mission data flow, scientific modeling and results in the fields of space and Earth physics, planning and design of GSFC VO DAAC and VO IMS, fabrication, assembly, and testing of mission instrumentation, and design of mission operations center.

SUPERFUND REMOTE SENSING SUPPORT

EPA Science Inventory

This task provides remote sensing technical support to the Superfund program. Support includes the collection, processing, and analysis of remote sensing data to characterize hazardous waste disposal sites and their history. Image analysis reports, aerial photographs, and assoc...

Urban Rail Supporting Technology Program Fiscal Year 1975 - Year End Summary

DOT National Transportation Integrated Search

1975-12-01

The Urban Rail Supporting Technology Program is described for the 1975 fiscal year period. Important areas include program management, technical support and applications engineering, facilities development, test and evaluation, and technology develop...

Analytical Components of the Benefits and Costs of the Clean Air Act 1990-2020, the Second Prospective Study

EPA Pesticide Factsheets

The major analytical components of the Second Prospective Study are shown on this page. For other major components of the study, supporting technical reports are available which provide additional technical information.

2013 Missouri Local Technical Assistance Program (LTAP) at Missouri S&T.

DOT National Transportation Integrated Search

2014-05-01

This project was established to provide training, information and technical assistance to local government agencies in Missouri. The : Missouri LTAP benefits UTC as an agent of technology transfer and also through the Missouri LTAP, UTC supports Miss...

EPA-SUPPORTED (ENVIRONMENTAL PROTECTION AGENCY-SUPPORTED) WASTELOAD ALLOCATION MODELS

EPA Science Inventory

Modeling is increasingly becoming part of the Wasteload Allocation Process. The U.S. EPA provides guidance, technical training and computer software in support of this program. This paper reviews the support available to modelers through the Wasteload Allocation Section of EPA's ...

Owning the program technical baseline for future space systems acquisition: program technical baseline tracking tool

NASA Astrophysics Data System (ADS)

Nguyen, Tien M.; Guillen, Andy T.; Hant, James J.; Kizer, Justin R.; Min, Inki A.; Siedlak, Dennis J. L.; Yoh, James

2017-05-01

The U.S. Air Force (USAF) has recognized the needs for owning the program and technical knowledge within the Air Force concerning the systems being acquired to ensure success. This paper extends the previous work done by the authors [1-2] on the "Resilient Program Technical Baseline Framework for Future Space Systems" and "Portfolio Decision Support Tool (PDST)" to the development and implementation of the Program and Technical Baseline (PTB) Tracking Tool (PTBTL) for the DOD acquisition life cycle. The paper describes the "simplified" PTB tracking model with a focus on the preaward phases and discusses how to implement this model in PDST.

Sustainable harvest, people and pandas: assessing a decade of managed wild harvest and trade in Schisandra sphenanthera.

PubMed

Brinckmann, J A; Luo, W; Xu, Q; He, X; Wu, J; Cunningham, A B

2018-06-05

Endemic to China, the distribution of Schisandra sphenanthera Rehder & E.H.Wilson includes giant panda (Ailuropoda melanoleuca David, 1869) habitats in forests of the Minshan and Qinling Mountains, both inside and outside conservation areas. The fruit is used in indigenous medicines of the Qiang, Tibetan and Yi ethnic minorities of Sichuan. Also used in traditional Chinese medicine (TCM), indications for use are prescribed in the Chinese Pharmacopoeia. For continued access and medical use, survival of healthy populations depends on forests. Biodiversity conservation programmes implemented in forests within the panda landscapes that also benefit rural and indigenous communities, link future access to wild medicinal plants with survival of the panda and resilient rural economies. This study aimed at assessing the project activities, institutional-level outcomes and achievements, 10 years on, of the 5-year (2007-2011) UNDP- and WWF- supported EU-China Biodiversity Programme for sustainable, "panda-friendly" schisandra. Our study combined analysis of quantitative data such as purchase records coupled with qualitative data obtained from field work, project documents, site-visit reports, certification documents and published articles about the project. At start of project, interested companies were identified to support economic viability of the sustainable wild harvesting and a "panda friendly" pro-conservation model that provided an incentive to maintain habitat outside formal protected areas. Criteria of relevant sustainability standards, the Organic Wild-crop Harvesting Practice Standard and FairWild Standard, were applied while a new standard was drafted, the Giant Panda Friendly Products Standard. The initial pilot project involving 1 village determined feasibility leading to formation of the Pingwu Shuijing TCM Cooperative which, by 2016, scaled out to membership of 22 villages. From the cooperative's first commercial sale of S. sphenanthera Rehder & E.H.Wilson fruits of 0.5 MT in 2009, annual quantities steadily increased up to 30 MT sold in 2017. The cooperative achieved organic certification in 2012. In 2016, governmental authorisation for the certification of Chinese operations implementing the FairWild Standard was granted. In 2017, the Giant Panda Friendly Products Standard became an official Chinese standard with the cooperative becoming the first panda-friendly certified operation in 2018. A decade after the project first started, there is strong evidence for the pro-conservation micro- and small enterprise model. For example, through the establishment of a TCM cooperative with members in 22 villages engaged in sustainable resource management, harvesting and equitable trade of TCM ingredients with organic and panda-friendly branding. The project benefited from multi-disciplinary collaboration of experts in ethnoecology, TCM, panda biology and habitat, nature conservation, sustainability standards and international trade. Inviting interested companies at the start enabled a transition from a funded-project to annual contracts for sustainably harvested TCM herbal drugs. At end of project (2011), the companies and NGOs remained engaged and motivating for completion of activities started during the project. Major eventual outcomes rooted in the initial project included Chinese government authorisation of the FairWild Standard (2016) and Giant Panda Friendly Products Standard (2017). Copyright © 2018. Published by Elsevier B.V.

Quality of Worklife and Higher Education Support Personnel: Testing the Generalizability of a Proposed Model

ERIC Educational Resources Information Center

Inoshita, Lynn T.

2012-01-01

Higher Education Support Personnel support the faculty in fulfilling the mission of America's colleges and universities. Rarely studied, these personnel include position classifications such as support/service professionals, technical/paraprofessionals, clerical and secretarial, service/maintenance, and skilled crafts. The support/service…

Prefocal station mechanical design concept study for the E-ELT

NASA Astrophysics Data System (ADS)

Jolley, Paul; Brunetto, Enzo; Frank, Christoph; Lewis, Steffan; Marchetti, Enrico

2016-07-01

The Nasmyth platforms of the E-ELT will contain one Prefocal Station (PFS) each. The main PFS functional requirements are to provide a focal plane to the three Nasmyth focal stations and the Coudé focus, optical sensing supporting telescope low order optimisation and seeing limited image quality, and optical sensing supporting characterising and phasing of M1 and other telescope subsystems. The PFS user requirements are used to derive the PFS technical requirements specification that will form the basis for design, development and production of the system. This specification process includes high-level architectural decisions and technical performance budget allocations. The mechanical design concepts reported here have been developed in order to validate key system specifications and associated technical budgets.

The role of non-technical skills in surgery

PubMed Central

Agha, Riaz A.; Fowler, Alexander J.; Sevdalis, Nick

2015-01-01

Non-technical skills are of increasing importance in surgery and surgical training. A traditional focus on technical skills acquisition and competence is no longer enough for the delivery of a modern, safe surgical practice. This review discusses the importance of non-technical skills and the values that underpin successful modern surgical practice. This narrative review used a number of sources including written and online, there was no specific search strategy of defined databases. Modern surgical practice requires; technical and non-technical skills, evidence-based practice, an emphasis on lifelong learning, monitoring of outcomes and a supportive institutional and health service framework. Finally these requirements need to be combined with a number of personal and professional values including integrity, professionalism and compassionate, patient-centred care. PMID:26904193

Kirtland Operations progress report, April--June 1991

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

Kirtland Operations (KO) is an integral part of EG G Energy Measurements, Inc., whose primary mission is to support the US Department of Energy's (DOE's) programs in weapons development and testing and in nuclear safeguards and security. KO performs much of its work in close coordination with and often at the technical direction of Sandia National Laboratories. In addition to aiding Sandia's weapons programs, KO provides a wide spectrum of technical support to other Sandia activities, particularly their safeguards, security, and treaty verification programs. Support is also provided to other elements of the Department of Energy community and to othermore » federal agencies, primarily in weapons testing and safeguards. This report documents our support to these programs from April to June 1991.« less

Kirtland Operations progress report, January--March 1991

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

Kirtland Operations (KO) is an integral part of EG G Energy Measurements, Inc., whose primary mission is to support the US Department of Energy's (DOE's) programs in weapons development and testing and in nuclear safeguards and security. KO performs much of its work in close coordination with and often at the technical direction of Sandia National Laboratories. In addition to aiding Sandia's weapons programs, KO provides a wide spectrum of technical support to other Sandia activities, particularly their safeguards, security, and treaty verification programs. Support is also provided to other elements of the Department of Energy community and to othermore » federal agencies, primarily in weapons testing and safeguards. This report documents our support to these porgrams from January to March 1991.« less

Kirtland Operations progress report, October--December 1991

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

Kirtland Operations (KO) is an integral part of EG G Energy Measurements, Inc., whose primary mission is to support the US Department of Energy's (DOE's) programs in weapons development and testing and in nuclear safeguards and security. KO performs much of its work in close coordination with and often at the technical direction of Sandia National Laboratories. In addition to aiding Sandia's weapons programs, KO provides a wide spectrum of technical support to other Sandia activities, particularly their safeguards, security, and treaty verification programs. Support is also provided to other elements of the Department of Energy community and to othermore » federal agencies, primarily in weapons testing and safeguards. This report documents our support to these programs from October to December 1991.« less

KMCLib 1.1: Extended random number support and technical updates to the KMCLib general framework for kinetic Monte-Carlo simulations

NASA Astrophysics Data System (ADS)

Leetmaa, Mikael; Skorodumova, Natalia V.

2015-11-01

We here present a revised version, v1.1, of the KMCLib general framework for kinetic Monte-Carlo (KMC) simulations. The generation of random numbers in KMCLib now relies on the C++11 standard library implementation, and support has been added for the user to choose from a set of C++11 implemented random number generators. The Mersenne-twister, the 24 and 48 bit RANLUX and a 'minimal-standard' PRNG are supported. We have also included the possibility to use true random numbers via the C++11 std::random_device generator. This release also includes technical updates to support the use of an extended range of operating systems and compilers.

[OurPuppet - Caring support with an interactive puppet for informal caregivers : Opportunities and challenges in the social and technical developmental process].

PubMed

Kuhlmann, Andrea; Reuter, Verena; Schramek, Renate; Dimitrov, Todor; Görnig, Matthias; Matip, Eva-Maria; Matthies, Olaf; Naroska, Edwin

2018-01-01

The "OurPuppet" project comprises a sensor-based, interactive puppet that will be developed to communicate with people in need of care during a short period of absence of the informal caregiver. Specially qualified puppet guides will support the use of the new technical development. They instruct people with dementia and caregivers on how to use the puppet and supervise the (informal) care relationship through discussions on a regular basis. The article shows the specific components of users' needs for which the concrete technical development should find answers. It also focuses on the opportunities and challenges for the technical and social developmental process accompanied by these demands. The analysis of the users' needs is based on a participatory approach. Semi-structured focus group interviews were conducted with informal caregivers, nurses and volunteers in order to identify typical situations in home care settings. The interviews were paraphrased and summarized in order to deduce inductive categories (qualitative data analysis), which describe everyday situations that the technical system should address. Such analyses provide information about the needs of potential users and indicate how to design such technical systems. Furthermore, opportunities and challenges of the development process as well as important contextual information were identified.

Identifying Potential Weapon Systems That Can Be Divested

DTIC Science & Technology

2016-04-08

List of Figures Figure 1.1 – TACOM LCMC Sustainment Systems Technical Support (SSTS) Operation Maintenance Army (OMA)……………………………………………………………………….6...LCMC Sustainment Systems Technical Support (SSTS) Operation Maintenance Army (OMA) Requirements Tracking System (TORTS) process used to develop...Force operational concepts (Peltz, 2003). The Army’s ability to keep systems operational from a maintenance standpoint is driven by two factors

International Space Station (ISS) Expedite the Process of Experiments to Space Station (EXPRESS) Racks Software Support

NASA Technical Reports Server (NTRS)

2003-01-01

bd Systems personnel accomplished the technical responsibilities for this reporting period, as planned. A close working relationship was maintained with personnel of the MSFC Avionics Department Software Group (ED 14), the MSFC EXPRESS Project Office (FD3 l), and the Huntsville Boeing Company. Work accomplishments included the support of SRB activities, ATB activities, ESCP activities, participating in technical meetings, coordinating issues between the Boeing Company and the MSFC Project Office, and performing special tasks as requested.

Sortie laboratory, phase B technical summary. [design and operational requirements

NASA Technical Reports Server (NTRS)

1973-01-01

The design and operational requirements which evolved from Sortie Lab (SL) analysis are summarized. A source of requirements for systems is given along with experimental support for the SL, baseline. Basic design data covered include: configuration definition, mission analysis, experimental integration, safety, and logistics. A technical summary outlines characteristics which reflect the influence of the growth in SL capability and the results of the mission and operational analysis. Each of the selected areas is described in terms of objectives, equipment, operational concept, and support requirements.

Methods and Costs to Achieve Ultra Reliable Life Support

NASA Technical Reports Server (NTRS)

Jones, Harry W.

2012-01-01

A published Mars mission is used to explore the methods and costs to achieve ultra reliable life support. The Mars mission and its recycling life support design are described. The life support systems were made triply redundant, implying that each individual system will have fairly good reliability. Ultra reliable life support is needed for Mars and other long, distant missions. Current systems apparently have insufficient reliability. The life cycle cost of the Mars life support system is estimated. Reliability can be increased by improving the intrinsic system reliability, adding spare parts, or by providing technically diverse redundant systems. The costs of these approaches are estimated. Adding spares is least costly but may be defeated by common cause failures. Using two technically diverse systems is effective but doubles the life cycle cost. Achieving ultra reliability is worth its high cost because the penalty for failure is very high.

The need for sustainability and alignment of future support for National Immunization Technical Advisory Groups (NITAGs) in low and middle-income countries.

PubMed

Howard, Natasha; Bell, Sadie; Walls, Helen; Blanchard, Laurence; Brenzel, Logan; Jit, Mark; Mounier-Jack, Sandra

2018-02-22

National Immunisation Technical Advisory Groups (NITAGs) provide independent guidance to health ministries to support evidence-based and nationally relevant immunisation decisions. We examined NITAGs' value, sustainability, and need for support in low and middle-income countries, drawing from a mixed-methods study including 130 global and national-level key informant interviews. NITAGs were particularly valued for providing independent and nationally owned evidence-based decision-making (EBDM), but needed to be integrated within national processes to effectively balance independence and influence. Participants agreed that most NITAGs, being relatively new, would need developmental and strengthening support for at least a decade. While national governments could support NITAG functioning, external support is likely needed for requisite capacity building. This might come from Gavi mechanisms and WHO, but would require alignment among stakeholders to be effective.

Definition of common support equipment and space station interface requirements for IOC model technology experiments

NASA Technical Reports Server (NTRS)

Russell, Richard A.; Waiss, Richard D.

1988-01-01

A study was conducted to identify the common support equipment and Space Station interface requirements for the IOC (initial operating capabilities) model technology experiments. In particular, each principal investigator for the proposed model technology experiment was contacted and visited for technical understanding and support for the generation of the detailed technical backup data required for completion of this study. Based on the data generated, a strong case can be made for a dedicated technology experiment command and control work station consisting of a command keyboard, cathode ray tube, data processing and storage, and an alert/annunciator panel located in the pressurized laboratory.

Characterizing the scientific potential of satellite sensors. [San Francisco, California

NASA Technical Reports Server (NTRS)

1984-01-01

Analytical and programming support is to be provided to characterize the potential of the LANDSAT thematic mapper (TM) digital imagery for scientific investigations in the Earth sciences and in terrestrial physics. In addition, technical support to define lower atmospheric and terrestrial surface experiments for the space station and technical support to the Research Optical Sensor (ROS) study scientist for advanced studies in remote sensing are to be provided. Eleven radiometric calibration and correction programs are described. Coherent noise and bright target saturation correction are discussed along with image processing on the LAS/VAX and Hp-300/IDIMS. An image of San Francisco, California from TM band 2 is presented.

10 CFR 603.420 - Disclosure of information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... types that are exempt: (i) Proposals, proposal abstracts, and supporting documents; and (ii) Business plans and technical information submitted on a confidential basis. (c) If proposers desire to protect business plans and technical information for five years from FOIA disclosure requirements, they must mark...

76 FR 6376 - Approval of Air Quality Implementation Plans; Indiana and Ohio; Disapproval of Interstate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... impact. EPA stated that the State's conclusion should be supported by an adequate technical analysis. EPA... technical analysis, no such analysis was provided by IDEM justifying that these measures are sufficient to... a State's [[Page 6379

Gateway National Recreational Area - Sandy Hook Unit : automated fee entrance plaza and intelligent transportation system technical requirements

DOT National Transportation Integrated Search

2009-01-01

The Volpe National Transportation Systems Center (Volpe Center) is providing technical : support to Sandy Hook, a unit of the Gateway National Recreation Area, in the planning and : concept development for possible Intelligent Transportation Systems ...

Security credentials management system (SCMS) design and analysis for the connected vehicle system : draft.

DOT National Transportation Integrated Search

2013-12-27

This report presents an analysis by Booz Allen Hamilton (Booz Allen) of the technical design for the Security Credentials Management System (SCMS) intended to support communications security for the connected vehicle system. The SCMS technical design...

Benefit Analysis Report, United States Air Force Technical Order Management Systems (AFTOMS)

DOT National Transportation Integrated Search

1989-08-01

This report prepared by the Transportation Systems Center (TSC) concludes an analysis of the Technical Order (TO) costs and benefits, which was originally undertaken as part of the US Air Force Computer-aided Acquisition and Logistics Support (CALS) ...

7 CFR 652.34 - Opportunity to contest decertification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE Decertification § 652.34 Opportunity to contest decertification. To contest decertification, the technical service provider must submit in writing to the State Conservationist, within 20 calendar days from the date of...

Preparing Students for Success in California's Community Colleges. Technical Appendix

ERIC Educational Resources Information Center

Mejia, Marisol Cuellar; Rodriguez, Olga; Johnson, Hans

2016-01-01

This document presents the technical appendix that accompanies the full report, "Preparing Students for Success in California's Community Colleges." The appendix includes Data and Methods. [Supported with funding from the Sutton Family Fund. For the full report, see ED570976.

Sustainable hydropower in Lower Mekong Countries: Technical assessment and training travel report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hadjerioua, Boualem; Witt, Adam M.

The U.S. Agency for International Development (USAID), through their partnership with the U.S. Department of the Interior (DOI), requested the support of Oak Ridge National Laboratory (ORNL) to provide specialized technical assistance as part of the Smart Infrastructure for the Mekong (SIM) Program in Thailand. Introduced in July 2013 by U.S. Secretary of State John Kerry, SIM is a U.S. Government Inter-Agency program that provides Lower Mekong partner countries with targeted, demand-driven technical and scientific assistance to support environmentally sound, climate conscious and socially equitable infrastructure, clean energy development, and water resources optimization. The U.S. Government is committed to supportingmore » sustainable economic development within the region by providing tools, best practices, technical assistance, and lessons learned for the benefit of partner countries. In response to a request from the Electricity Generating Authority of Thailand (EGAT), a SIM project was developed with two main activities: 1) to promote hydropower sustainability and efficiency through technical assessment training at two existing hydropower assets in Thailand, and 2) the design and implementation of one national and two or three regional science and policy workshops, to be co-hosted with EGAT, to build common understanding of and commitment to environmental and social safeguards for Mekong Basin hydropower projects. The U.S. Department of Energy (DOE) is leading the technical assessment (Activity 1), and has contracted ORNL to provide expert technical assistance focused on increasing efficiency at existing projects, with the goal of increasing renewable energy generation at little to no capital cost. ORNL is the leading national laboratory in hydropower analysis, with a nationally recognized and highly qualified team of scientists addressing small to large-scale systems (basin-, regional-, and national-scale) energy generation optimization analysis for DOE. The mission of the ORNL Water Power Program is to develop technologies, decision-support tools, and methods of analysis that enable holistic management of water-dependent energy infrastructure and natural resources in support of the DOE Energy Efficiency and Renewable Energy Office (DOE-EERE), Federal hydropower agencies, Federal Energy Regulatory Commission (FERC), Nuclear Regulatory Commission (NRC), energy producers, and other entities. In support of SIM, ORNL completed technical assessments of two hydropower plants owned and operated by the Electricity Generating Authority of Thailand (EGAT): Vajiralongkorn (VRK), with an installed capacity of 300 MW, and Rajjaprabha (RPB), with an installed capacity of 240MW. Technical assessment is defined as the assessment of hydropower operation and performance, and the identification of potential opportunities for performance improvement through plant optimization. At each plant, the assessment included an initial analysis of hydropower operating and performance metrics, provided by dam owners. After this analysis, ORNL engaged with the plant management team in a skills exchange, where best practices, operational methods, and technical challenges were discussed. The technical assessment process was outlined to plant management followed by a presentation of preliminary results and analysis based on 50 days of operational data. EGAT has agreed to provide a full year of operational data so a complete and detailed assessment that captures seasonal variability can be completed. The results of these assessments and discussions will be used to develop a set of best practices, training, and procedure recommendations to improve the efficiency of the two assessed plants« less

A Meta-Analysis of Motivational Interviewing Process: Technical, Relational, and Conditional Process Models of Change

PubMed Central

Magill, Molly; Apodaca, Timothy R.; Borsari, Brian; Gaume, Jacques; Hoadley, Ariel; Gordon, Rebecca E.F.; Tonigan, J. Scott; Moyers, Theresa

2018-01-01

Objective In the present meta-analysis, we test the technical and relational hypotheses of Motivational Interviewing (MI) efficacy. We also propose an a priori conditional process model where heterogeneity of technical path effect sizes should be explained by interpersonal/relational (i.e., empathy, MI Spirit) and intrapersonal (i.e., client treatment seeking status) moderators. Method A systematic review identified k = 58 reports, describing 36 primary studies and 40 effect sizes (N = 3025 participants). Statistical methods calculated the inverse variance-weighted pooled correlation coefficient for the therapist to client and the client to outcome paths across multiple target behaviors (i.e., alcohol use, other drug use, other behavior change). Results Therapist MI-consistent skills were correlated with more client change talk (r = .55, p < .001) as well as more sustain talk (r = .40, p < .001). MI-inconsistent skills were correlated with more sustain talk (r = .16, p < .001), but not change talk. When these indicators were combined into proportions, as recommended in the Motivational Interviewing Skill Code, the overall technical hypothesis was supported. Specifically, proportion MI consistency was related to higher proportion change talk (r = .11, p = .004) and higher proportion change talk was related to reductions in risk behavior at follow up (r = −.16, p < .001). When tested as two independent effects, client change talk was not significant, but sustain talk was positively associated with worse outcome (r = .19, p < .001). Finally, the relational hypothesis was not supported, but heterogeneity in technical hypothesis path effect sizes was partially explained by inter- and intra-personal moderators. Conclusions This meta-analysis provides additional support for the technical hypothesis of MI efficacy; future research on the relational hypothesis should occur in the field rather than in the context of clinical trials. PMID:29265832

A meta-analysis of motivational interviewing process: Technical, relational, and conditional process models of change.

PubMed

Magill, Molly; Apodaca, Timothy R; Borsari, Brian; Gaume, Jacques; Hoadley, Ariel; Gordon, Rebecca E F; Tonigan, J Scott; Moyers, Theresa

2018-02-01

In the present meta-analysis, we test the technical and relational hypotheses of Motivational Interviewing (MI) efficacy. We also propose an a priori conditional process model where heterogeneity of technical path effect sizes should be explained by interpersonal/relational (i.e., empathy, MI Spirit) and intrapersonal (i.e., client treatment seeking status) moderators. A systematic review identified k = 58 reports, describing 36 primary studies and 40 effect sizes (N = 3,025 participants). Statistical methods calculated the inverse variance-weighted pooled correlation coefficient for the therapist to client and the client to outcome paths across multiple target behaviors (i.e., alcohol use, other drug use, other behavior change). Therapist MI-consistent skills were correlated with more client change talk (r = .55, p < .001) as well as more sustain talk (r = .40, p < .001). MI-inconsistent skills were correlated with more sustain talk (r = .16, p < .001), but not change talk. When these indicators were combined into proportions, as recommended in the Motivational Interviewing Skill Code, the overall technical hypothesis was supported. Specifically, proportion MI consistency was related to higher proportion change talk (r = .11, p = .004) and higher proportion change talk was related to reductions in risk behavior at follow up (r = -.16, p < .001). When tested as two independent effects, client change talk was not significant, but sustain talk was positively associated with worse outcome (r = .19, p < .001). Finally, the relational hypothesis was not supported, but heterogeneity in technical hypothesis path effect sizes was partially explained by inter- and intrapersonal moderators. This meta-analysis provides additional support for the technical hypothesis of MI efficacy; future research on the relational hypothesis should occur in the field rather than in the context of clinical trials. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

MHD program plan, FY 1991

NASA Astrophysics Data System (ADS)

1990-10-01

The current magnetohydrodynamic MHD program being implemented is a result of a consensus established in public meetings held by the Department of Energy in 1984. The public meetings were followed by the formulation of a June 1984 Coal-Fired MHD Preliminary Transition and Program Plan. This plan focused on demonstrating the proof-of-concept (POC) of coal-fired MHD electric power plants by the early 1990s. MHD test data indicate that while there are no fundamental technical barriers impeding the development of MHD power plants, technical risk remains. To reduce the technical risk three key subsystems (topping cycle, bottoming cycle, and seed regeneration) are being assembled and tested separately. The program does not require fabrication of a complete superconducting magnet, but rather the development and testing of superconductor cables. The topping cycle system test objectives can be achieved using a conventional iron core magnet system already in place at a DOE facility. Systems engineering-derived requirements and analytical modeling to support scale-up and component design guide the program. In response to environmental, economic, engineering, and utility acceptance requirements, design choices and operating modes are tested and refined to provide technical specifications for meeting commercial criteria. These engineering activities are supported by comprehensive and continuing systems analyses to establish realistic technical requirements and cost data. Essential elements of the current program are to: develop technical and environmental data for the integrated MHD topping cycle and bottoming cycle systems through POC testing (1000 and 4000 hours, respectively); design, construct, and operate a POC seed regeneration system capable of processing spent seed materials from the MHD bottoming cycle; prepare conceptual designs for a site specific MHD retrofit plant; and continue supporting research necessary for system testing.

CAT--the new committee for advanced therapies at the European Medicines Agency.

PubMed

Celis, P

2010-01-01

The Regulation on Advanced Therapies (Regulation (EC) 1394/2007) establishes a new scientific committee, the Committee for Advanced Therapies (CAT), at the European Medicines Agency. The CAT is composed of experts in the field of Advanced Therapy Medicinal Products (ATMPs)--gene and cell therapy and tissue engineered products--and is responsible for the evaluation of the marketing authorisation applications for this novel class of products. The CAT is also involved in all scientific advice on ATMPs and in two new regulatory procedures for ATMPs, the classification and the certification procedures. The CAT will also play a key role in early contacts with developers of ATMPs.

On-Line Databases in Mexico.

ERIC Educational Resources Information Center

Molina, Enzo

1986-01-01

Use of online bibliographic databases in Mexico is provided through Servicio de Consulta a Bancos de Informacion, a public service that provides information retrieval, document delivery, translation, technical support, and training services. Technical infrastructure is based on a public packet-switching network and institutional users may receive…

SWIFT Differentiated Technical Assistance. White Paper

ERIC Educational Resources Information Center

McCart, Amy; McSheehan, Michael; Sailor, Wayne; Mitchiner, Melinda; Quirk, Carol

2016-01-01

The Schoolwide Integrated Framework for Transformation (SWIFT) employs six technical assistance (TA) practices that support an initial transformation process while simultaneously building system capacity to sustain and scale up equity-based inclusion in additional schools and districts over time. This paper explains these individual practices and…

14 CFR 1260.71 - Supplements and renewals.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., continued research relevance, and progress made by the recipient. (2) To insure uninterrupted programs, the technical office should forward to the grant office a completed award package, including a funded procurement request, technical evaluation of the proposed budget, and other support documentation, at least 29...

Waste Receiving and Processing (WRAP) Module 1 Hazards Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

CAMPBELL, L.R.

1999-09-29

This document establishes the technical basis in support of Emergency Planning activities for the WRAP Module 1 Facility on the Hanford Site. Through this document, the technical basis for the development of facility specific Emergency Action Levels and Emergency Planning Zone is demonstrated.

Technical Operating Procedures for Resource Documentation Under the Oil Pollution Act of 1990

DOT National Transportation Integrated Search

1996-06-01

Technical Operating Procedures (TOPs) for Resource Documentation under the Oil Pollution Act of 1990 (P.L.101-380) have been developed to provide guidance to users operating as, or in support of, the Federal On-Scene Coordinator(FOSC). The procedures...

[Sanitary epidemiologic safety and technical regulations on railway transport].

PubMed

Leksin, A G

2009-01-01

The author necessitated that requirements on sanitary and epidemiologic safety of life support systems for engine driver cabin (microclimate maintainance system, protection from vibration and noise, illumination, workplace ergonomics, etc) should be included into technical regulations for railway vehicles, both newly constructed and modernized.

Memory effects in stock price dynamics: evidences of technical trading

PubMed Central

Garzarelli, Federico; Cristelli, Matthieu; Pompa, Gabriele; Zaccaria, Andrea; Pietronero, Luciano

2014-01-01

Technical trading represents a class of investment strategies for Financial Markets based on the analysis of trends and recurrent patterns in price time series. According standard economical theories these strategies should not be used because they cannot be profitable. On the contrary, it is well-known that technical traders exist and operate on different time scales. In this paper we investigate if technical trading produces detectable signals in price time series and if some kind of memory effects are introduced in the price dynamics. In particular, we focus on a specific figure called supports and resistances. We first develop a criterion to detect the potential values of supports and resistances. Then we show that memory effects in the price dynamics are associated to these selected values. In fact we show that prices more likely re-bounce than cross these values. Such an effect is a quantitative evidence of the so-called self-fulfilling prophecy, that is the self-reinforcement of agents' belief and sentiment about future stock prices' behavior. PMID:24671011

Memory effects in stock price dynamics: evidences of technical trading

NASA Astrophysics Data System (ADS)

Garzarelli, Federico; Cristelli, Matthieu; Pompa, Gabriele; Zaccaria, Andrea; Pietronero, Luciano

2014-03-01

Technical trading represents a class of investment strategies for Financial Markets based on the analysis of trends and recurrent patterns in price time series. According standard economical theories these strategies should not be used because they cannot be profitable. On the contrary, it is well-known that technical traders exist and operate on different time scales. In this paper we investigate if technical trading produces detectable signals in price time series and if some kind of memory effects are introduced in the price dynamics. In particular, we focus on a specific figure called supports and resistances. We first develop a criterion to detect the potential values of supports and resistances. Then we show that memory effects in the price dynamics are associated to these selected values. In fact we show that prices more likely re-bounce than cross these values. Such an effect is a quantitative evidence of the so-called self-fulfilling prophecy, that is the self-reinforcement of agents' belief and sentiment about future stock prices' behavior.

Underground Test Area Activity Preemptive Review Guidance Nevada National Security Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Farnham, Irene; Rehfeldt, Kenneth

Preemptive reviews (PERs) of Underground Test Area (UGTA) Activity corrective action unit (CAU) studies are an important and long-maintained quality improvement process. The CAU-specific PER committees provide internal technical review of ongoing work throughout the CAU lifecycle. The reviews, identified in the UGTA Quality Assurance Plan (QAP) (Sections 1.3.5.1 and 3.2), assure work is comprehensive, accurate, in keeping with the state of the art, and consistent with CAU goals. PER committees review various products, including data, documents, software/codes, analyses, and models. PER committees may also review technical briefings including Federal Facility Agreement and Consent Order (FFACO)-required presentations to the Nevadamore » Division of Environmental Protection (NDEP) and presentations supporting key technical decisions (e.g., investigation plans and approaches). PER committees provide technical recommendations to support regulatory decisions that are the responsibility of the U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Field Office (NNSA/NFO) and NDEP.« less